> ## Documentation Index > Fetch the complete documentation index at: https://docs.udiconnect.io/llms.txt > Use this file to discover all available pages before exploring further. # EUDAMED MDR Submit > Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). ## OpenAPI ````yaml post /api/v1/submit/EU_UDI_MDR openapi: 3.1.0 info: title: OpenAPI definition version: v0 servers: - url: https://api.udiconnect.io description: P36 UDI Hub API Server security: - ApiKeyAuth: [] paths: /api/v1/submit/EU_UDI_MDR: post: tags: - Submission summary: Submit UDI data to regulatory agency description: >- Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). operationId: submitUdiData parameters: [] requestBody: description: Data to be submitted content: application/json: schema: $ref: '#/components/schemas/SubmissionRequest' examples: Valid Request: description: A valid request for submitting a new data model value: | { "actorCode": "DE-MF-000001723", "device": { "IssuingAgency": "GS1", "Device": "00308676965723", "DeviceGroup": "439990237188JM", "Material": "37588-474", "BaseQuantity": 1, "CommercialDistributionStatus": "ON_THE_MARKET", "ProductionIdentifier": [ "BATCH_NUMBER" ], "ReferenceNumber": "37588-474", "MDN": [ "A0101010201" ], "NumberOfReuses": 0, "ContainsLatex": false, "Reprocessed": false, "Sterile": false, "ReqSterilizatonPriorUse": true, "MarketInfos": [ { "Country": "DE", "OriginalPlacedOnTheMarket": true } ], "AdditionalTradeNames": [ { "AdditionalTradeName": "Trade Name", "AdditionalTradeNameLanguage": "EN" } ] }, "deviceGroup": { "DeviceGroupAgency": "GS1", "DeviceGroup": "439990237188JM", "ApplicableLegislation": "MDR", "MFActorCode": "DE-MF-000001723", "DeviceName": "Device Name", "RiskClass": "CLASS_I", "AnimalTissuesCells": false, "HumanTissuesCells": false, "DeviceImplantable": false, "DeviceHasMeasuringFunction": false, "DeviceReusableSurgicalInstrument": false, "ActiveDevice": false, "DeviceIntendedToAdministerMedicine": false, "SystemDevice": false, "ProcedurePackDevice": false, "HumanProductCheck": false, "MedicinalProductCheck": false } } Full Data Example: description: Full Data Example value: | { "actorCode": "DE-MF-000001723", "device": { "Device": "00363932443216", "IssuingAgency": "GS1", "ReferenceNumber": "12345", "Material": "123456-001", "MaterialText": "p36 Test Device - Direct Marking / DC 1", "DeviceGroup": "439990280203HW", "MDN": [ "A0101010101" ], "Packages": [ { "Status": "ON_THE_MARKET", "PackagingDi": "00359412962322", "NumberOfItems": 10, "ChildIssuingAgency": "GS1", "Child": "00363932443216" } ], "ClinicalSizes": [], "ProductionIdentifier": [ "MANUFACTURING_DATE", "BATCH_NUMBER" ], "ApplicableLegislation": "MDR", "MFActorCode": "DE-MF-000001723", "ReqSterilizatonPriorUse": true, "AdditionalTradeNames": [ { "AdditionalTradeName": "p36 Test Device", "AdditionalTradeNameLanguage": "EN" } ], "BaseQuantity": 1, "Sterile": false, "Reprocessed": false, "ContainsLatex": false, "DirectMarkingDiIssuingAgency": "GS1", "DirectMarkingDi": "00329299513788", "AdditionalDeviceDescriptions": [ { "AdditionalDeviceDescription": "p36 Test Device", "AdditionalDeviceDescriptionLanguage": "EN" } ], "NumberOfReuses": -1, "MarketInfos": [ { "OriginalPlacedOnTheMarket": true, "Country": "DE" } ], "SecondaryDiAgency": "0", "CommercialDistributionStatus": "ON_THE_MARKET" }, "deviceGroup": { "DeviceGroup": "439990280203HW", "RiskClass": "CLASS_I", "Certificates": [], "UdiDis": [], "ActiveDevice": false, "DeviceReusableSurgicalInstrument": false, "SpecialDeviceType": "0", "DeviceGroupAgency": "GS1", "HumanTissuesCells": false, "ProcedurePackDevice": false, "DeviceHasMeasuringFunction": false, "AnimalTissuesCells": false, "DeviceIntendedToAdministerMedicine": false, "SystemDevice": false, "ApplicableLegislation": "MDR", "DeviceImplantable": false, "ClinicalInvestigations": [ { "NonEUApplicableCountries": "US", "Reference": "123-ABC-456" } ], "MFActorCode": "DE-MF-000001723", "DeviceName": "MDR Low Risk BUDI Test Device", "MedicinalProductCheck": false, "HumanProductCheck": false, "DeviceImplantableExceptions": null } } required: true responses: '200': description: Submission processed successfully content: application/json: schema: $ref: '#/components/schemas/SubmissionSuccessResponse' examples: Submission Successful: description: Submission Successful value: |- { "agency": "EC", "requestId": "string", "modelInformation": "string", "status": "SUCCESS", "statusText": "Submission successfully validated and accepted" } '400': description: Submission data validation failed content: application/json: schema: $ref: '#/components/schemas/SubmissionValidationErrorResponse' examples: Submission Validation Error: description: Submission Validation Error value: |- { "status": "failed", "message": "Validation failed", "deviceErrors": [ { "path": "string", "message": "string", "ruleId": "string" } ], "deviceGroupErrors": [ { "path": "string", "message": "string", "ruleId": "string" } ] } '409': description: >- Submission blocked - Request cannot be processed due to business rules content: application/json: schema: $ref: '#/components/schemas/SubmissionBlockedResponse' examples: Submission Blocked: description: Submission Blocked value: |- { "agency": "EC", "requestId": "string", "modelInformation": "string", "status": "BLOCKED", "statusText": "Submission blocked due to business rules", "reasons": [ "Entity X is not submittable because of its current state (In Submission) " ] } '500': description: Technical processing error - Internal server error occurred content: application/json: schema: $ref: '#/components/schemas/SubmissionTechnicalErrorResponse' examples: Internal Server Error: description: Internal Server Error value: |- { "timestamp": "string", "status": 500, "error": "Internal Server Error", "message": "string" } components: schemas: SubmissionRequest: type: object properties: actorCode: type: string securityToken: type: string device: $ref: '#/components/schemas/DEVICE_EU_UDI_MDR' description: required for all EC submissions deviceGroup: $ref: '#/components/schemas/DEVICE_GROUP_EU_UDI_MDR' description: required for all EC submissions if not already submitted & published SubmissionSuccessResponse: type: object description: Response for successful submission processing properties: agency: type: string description: Regulatory agency information enum: - COMMON_DEVICE_DATA - FDA - EC - NMPA - MFDS - GDSN - SFDA - TFDA - TGA - HSA requestId: type: string description: The unique identifier for the submission request modelInformation: type: string description: >- Information about the model and use case data used for processing the request status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED statusText: type: string description: Description of the status SubmissionValidationErrorResponse: type: object description: Response for validation failures during submission processing properties: agency: type: string description: Regulatory agency information enum: - COMMON_DEVICE_DATA - FDA - EC - NMPA - MFDS - GDSN - SFDA - TFDA - TGA - HSA requestId: type: string description: The unique identifier for the submission request modelInformation: type: string description: >- Information about the model and use case data used for processing the request status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED statusText: type: string description: Description of the status validationResult: $ref: '#/components/schemas/ValidationResponse' description: Detailed information about the validation failures SubmissionBlockedResponse: type: object description: Response for blocked submissions due to business rules properties: agency: type: string description: Regulatory agency information enum: - COMMON_DEVICE_DATA - FDA - EC - NMPA - MFDS - GDSN - SFDA - TFDA - TGA - HSA requestId: type: string description: The unique identifier for the submission request modelInformation: type: string description: >- Information about the model and use case data used for processing the request status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED statusText: type: string description: Description of the status reasons: type: array description: List of reasons why the submission was blocked items: type: string SubmissionTechnicalErrorResponse: type: object description: Response for technical errors during submission processing properties: agency: type: string description: Regulatory agency information enum: - COMMON_DEVICE_DATA - FDA - EC - NMPA - MFDS - GDSN - SFDA - TFDA - TGA - HSA requestId: type: string description: The unique identifier for the submission request modelInformation: type: string description: >- Information about the model and use case data used for processing the request status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED statusText: type: string description: Description of the status reasons: type: array description: List of errors that occurred during submission processing items: type: string DEVICE_EU_UDI_MDR: type: object properties: OrgUnit: type: string UnitOfUseDi: type: string description: >- Unit of Use DI - reference to the Unit of Use DI applicable for the current UDI-DI (Device Identifier). A virtual identifier assigned to an individual medical device when a Unique Device Identifier (UDI) is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient when a base package contains more than one device.\n\nField is mandatory when the value of the field Direct marking is false and Quantity of Device is more than 1 Certificates: type: object properties: CertificateType: type: string enum: - MDR_PRODUCT_VERIFICATION - MDR_QUALITY_ASSURANCE - MDR_QUALITY_MANAGEMENT_SYSTEM - MDR_TECHNICAL_DOCUMENTATION - MDR_TYPE_EXAMINATION NotifiedBodyActorCode: type: string enum: - '0044' - '0050' - '0051' - '0068' - '0123' - '0124' - '0197' - '0297' - '0318' - '0333' - '0344' - '0373' - '0425' - '0426' - '0459' - '0476' - '0477' - '0482' - '0483' - '0494' - '0537' - '0546' - '0598' - '0633' - '1011' - '1023' - '1282' - '1304' - '1370' - '1383' - '1434' - '1639' - '1912' - '1936' - '1984' - '2265' - '2274' - '2292' - '2409' - '2443' - '2460' - '2696' - '2764' - '2797' - '2803' - '2862' - '2962' - '2975' - '3022' - '3033' CertificateNumber: type: string CertificateRevisionNumber: type: string DeviceGroup: type: string description: Reference to the Basic UDI-DI to which the Device is associated DeviceReusableSurgicalInstrument: type: boolean SpecialDeviceType: type: string enum: - '0' - MDR_MADE_TO_ORDER - MDR_ORTHOPEDIC - MDR_READY_MADE_SPECTACLES - MDR_RIGID_GAS_PERMEABLE - MDR_SOFTWARE - MDR_SPECTACLES_FRAMES - MDR_SPECTACLES_LENSES - MDR_STANDARD_SOFT_CONTACT_LENSES Substances: type: object description: References to the Substances associated to the device maxItems: 0 minItems: 0 properties: INN: type: string description: >- Field stores the INN value for the substance provided.\n\nINN can be provided only for substances which, if used separately, may be considered to be a medicinal product or substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma SubType: type: string description: >- Field stores the Type of CMR Substance. It is only applicable when the Substance registered is a CMR Substance enum: - CMR_1A - CMR_1B - ENDOCRINE_DISRUPTING SubstanceType: type: string description: >- Field stores the details regarding the type of substance registered (Substance which can be considered a Medicinal Product, Substance which may be considered a medicinal product derived from human blood or plasma or CMR Substance) enum: - CRM_ENDOCRINE - HUMAN_PRODUCT_SUBSTANCE - MEDICINAL_PRODUCT_SUBSTANCE CASCode: type: string description: >- Field stores the CAS Code (CAS#) associated to the CMR substance.\n\nCAS# can be provided only for CMR or Endocrine-disrupting substances SubstanceNameLocalized: type: string description: >- When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances\n\nField stores the Name of Substance (applicable for all types of substances - CMR, Endocrine , Medicinal product, Medicinal product derived from human blood or human). \n\nIn case of CMR Substances or Medicinal product and Medicinal product derived from human blood or human plasma , if the #CAS or #EC or INN is provided, field is no longer required ECCode: type: string description: >- Field Stores the EC Code (EC#)associated to the CMR or Endocrine disrupting substance.\n\nEC# can be provided only for CMR or Endocrine-disrupting substances required: - SubstanceNameLocalized - SubstanceType HumanTissuesCells: type: boolean MDN: type: string description: >- The Device Nomenclature Code(s) associated with the UDI-DI. \nThe corresponding EMDN Nomenclature Code will be stored in the field\n\n enum: - A0101010101 - A0101010102 - A0101010201 - A0101010202 - A01010199 - A01010201 - A01010202 - A01010301 - A01010302 - A010104 - A01010501 - A01010502 - A010106 - A01018001 - A01018099 - A010199 - A0102010101 - A0102010102 - A01020102 - A01020199 - A01020201 - A01020202 - A01020203 - A01020204 - A01020299 - A01020301 - A01020302 - A01020303 - A01020399 - A01020401 - A01020402 - A01020501 - A01020502 - A01020599 - A010206 - A010207 - A010299 - A01030101 - A01030102 - A01030103 - A010302 - A010399 - A010401 - A010480 - A010499 - A010501 - A010502 - A010503 - A010504 - A010505 - A010506 - A010599 - A010601 - A010602 - A010699 - A018001 - A018002 - A018003 - A018004 - A018005 - A018006 - A018099 - A019001 - A019002 - A019003 - A019004 - A019005 - A019006 - A019007 - A019008 - A019009 - A019010 - A019011 - A019012 - A019013 - A019014 - A019015 - A019016 - A019099 - A0199 - A020101 - A020102010101 - A020102010102 - A020102010201 - A020102010202 - A020102020101 - A020102020102 - A02010203 - A02010204 - A02010205 - A02010299 - A02010401 - A02010499 - A02010501 - A02010502 - A02010601 - A02010602 - A0201060301 - A0201060302 - A02010699 - A02010701 - A02010702 - A02010799 - A020108 - A020109 - A020199 - A020201 - A020202 - A020203 - A020299 - A0280 - A0299 - A03010101 - A03010102 - A03010103 - A03010104 - A03010105 - A03010199 - A03010201 - A03010202 - A03010299 - A03010301 - A03010302 - A03010399 - A030104 - A030105 - A030199 - A03020101 - A03020102 - A03020199 - A0303 - A03040101 - A03040102 - A03040199 - A03040201 - A03040202 - A03040203 - A03040204 - A03040299 - A030403 - A030499 - A0380 - A0399 - A04010101 - A04010102 - A04010199 - A040180 - A040199 - A0499 - A05010101 - A05010102 - A05010201 - A05010202 - A0502 - A0580 - A0599 - A0601010101 - A0601010102 - A0601010103 - A0601010199 - A0601010201 - A0601010299 - A06010103 - A0601010401 - A0601010402 - A0601010403 - A0601010499 - A06010199 - A060102 - A060199 - A060201 - A060202 - A060203 - A060204 - A060205 - A060206 - A060299 - A060301 - A060302 - A06030301 - A06030302 - A06030399 - A06030401 - A06030499 - A060399 - A0680 - A0699 - A070101 - A070102 - A070103 - A070199 - A0702 - A0703 - A0704 - A070501 - A07050201 - A07050202 - A070599 - A0706 - A0799 - A080101 - A080102 - A080199 - A080201 - A080299 - A088001 - A088099 - A0899 - A090101 - A090199 - A0980 - A0999 - A1001010101 - A1001010102 - A1001010201 - A1001010202 - A1001020101 - A1001020102 - A1001020201 - A1001020202 - A1001030101 - A1001030102 - A1001030201 - A1001030202 - A100104 - A100199 - A1002010101 - A1002010102 - A1002010201 - A1002010202 - A1002010301 - A1002010302 - A1002010401 - A1002010402 - A10020201 - A10020202 - A10020301 - A10020302 - A10020401 - A10020402 - A100205 - A100299 - A100301 - A100302 - A100399 - A108001 - A108002 - A108003 - A108004 - A108005 - A108006 - A108007 - A108008 - A108009 - A108099 - A1099 - A1101 - A1102 - A12 - A13 - A99 - B0101010101 - B0101010199 - B0101010201 - B0101010202 - B0101010203 - B0101010299 - B0101020101 - B0101020102 - B0101020199 - B0101020201 - B0101020202 - B0101020299 - B010199 - B010201 - B010202 - B010299 - B0103 - B010401 - B010402 - B010403 - B010499 - B0105 - B0180 - B019001 - B019002 - B019003 - B019004 - B0199 - B02010101 - B02010102 - B02010199 - B02010201 - B02010202 - B02010299 - B020201 - B020202 - B0280 - B0299 - B030101 - B030102 - B030103 - B030104 - B030199 - B030201 - B030202 - B030203 - B030204 - B030299 - B0380 - B0399 - B0401 - B0402 - B0480 - B0499 - B0501 - B0502 - B0599 - B06 - B07 - B99 - C0101010101 - C0101010102 - C0101010201 - C0101010202 - C01010103 - C01010180 - C01010199 - C010102 - C010103 - C010104 - C010180 - C010199 - C01020101 - C01020102 - C01020201 - C01020202 - C01020203 - C01020301 - C01020302 - C01020303 - C01020401 - C01020402 - C01020499 - C010280 - C010299 - C010301 - C010302 - C010303 - C010380 - C010399 - C0104010101 - C0104010102 - C0104010199 - C010401020101 - C010401020102 - C010401020180 - C010401020199 - C0104010202 - C0104010203 - C010401020401 - C010401020402 - C010401020480 - C010401020499 - C010401020501 - C010401020502 - C010401020580 - C0104010280 - C0104010299 - C01040180 - C01040199 - C0104020101 - C0104020102 - C0104020103 - C0104020180 - C0104020199 - C010402020101 - C010402020102 - C010402020180 - C010402020199 - C0104020202 - C010402020301 - C010402020302 - C010402020303 - C010402020380 - C010402020399 - C0104020204 - C0104020205 - C010402020601 - C010402020602 - C010402020680 - C010402020699 - C010402020701 - C010402020702 - C010402020780 - C0104020208 - C0104020209 - C0104020280 - C0104020299 - C01040280 - C01040299 - C010403 - C010480 - C010499 - C01050101 - C01050102 - C01050201 - C01050202 - C01050203 - C01050299 - C010580 - C010599 - C0180 - C019001 - C019002 - C019003 - C019004 - C019005 - C019006 - C019007 - C019008 - C019009 - C019010 - C01901101 - C01901102 - C01901201 - C01901202 - C019013 - C019014 - C019015 - C019016 - C019017 - C019018 - C01901901 - C01901902 - C01901903 - C01901999 - C019020 - C0199 - C020101 - C020102 - C020103 - C02010401 - C02010402 - C02010403 - C02010499 - C020105 - C020180 - C020199 - C020201 - C020202 - C020203 - C020280 - C020299 - C020301 - C020302 - C020304 - C020305 - C020380 - C020399 - C020401 - C02040201 - C02040202 - C02040299 - C020480 - C020499 - C020501 - C020599 - C0280 - C0299 - C03010101 - C03010102 - C03010104 - C03010199 - C030102 - C03010301 - C03010399 - C0301040101 - C0301040102 - C0301040201 - C0301040202 - C03010403 - C0301040401 - C0301040402 - C0301040499 - C03010405 - C03010406 - C03010499 - C030180 - C030199 - C0380 - C03900101 - C03900102 - C03900201 - C03900202 - C03900203 - C03900299 - C0399 - C04010101 - C04010102 - C04010199 - C04010201 - C04010202 - C04010299 - C04020101 - C04020102 - C04020199 - C04020201 - C04020202 - C04020299 - C04030101 - C04030102 - C04030199 - C04030201 - C04030202 - C04030299 - C0480 - C0499 - C0501 - C0502 - C0503 - C0504 - C058001 - C058099 - C0599 - C0601 - C0602 - C0603 - C0699 - C900101 - C900102 - C90010301 - C90010302 - C90010303 - C90010399 - C900180 - C900199 - C9002 - C900301 - C900399 - C9005 - C9006 - C9080 - C99 - D01010101 - D01010102 - D01010103 - D01010201 - D010103 - D010199 - D0199 - D02010101 - D02010102 - D02010199 - D020102 - D020199 - D0299 - D03010101 - D03010102 - D03010199 - D030102 - D030103 - D030199 - D0302 - D030301 - D030302 - D030399 - D0399 - D050101 - D050102 - D050103 - D050199 - D0502 - D0599 - D06010101 - D06010199 - D060102 - D060199 - D0699 - D0701 - D0702 - D0799 - D0801 - D0899 - D0901 - D0902 - D99 - F01060101 - F01060102 - F01060103 - F01060199 - F01060201 - F01060202 - F01060203 - F01060299 - F01060301 - F01060302 - F01060303 - F01060399 - F010604 - F010701 - F010702 - F010799 - F01080101 - F01080102 - F01080201 - F01080202 - F0109 - F0199 - F020101 - F020102 - F020104 - F020180 - F020199 - F02020101 - F02020102 - F02020199 - F02020201 - F02020202 - F02020299 - F020280 - F020299 - F0299 - F0301 - F0302 - F0303 - F0304 - F0305 - F0306 - F0307 - F0399 - F040101 - F040102 - F040201 - F040202 - F040302 - F040399 - F0404 - F0499 - F05 - F900101 - F900199 - F900201 - F900202 - F900299 - F900301 - F900302 - F90040101 - F90040102 - F900402 - F9006 - F9080 - F9099 - G010101 - G010102 - G010199 - G010201 - G010202 - G010299 - G010301 - G010302 - G010303 - G010304 - G010305 - G010399 - G0180 - G0199 - G020101 - G020102 - G020199 - G02020101 - G02020102 - G02020199 - G02020201 - G02020202 - G02020203 - G020299 - G020301 - G020399 - G020401 - G020402 - G020499 - G020501 - G020502 - G020503 - G020599 - G02060101 - G02060102 - G02060199 - G02060201 - G02060202 - G02060299 - G02060301 - G02060302 - G02060303 - G02060304 - G02060305 - G02060399 - G0280 - G0299 - G0301010101 - G0301010102 - G0301010201 - G0301010202 - G0301010301 - G0301010302 - G0301010401 - G0301010402 - G0301010501 - G0301010502 - G03010199 - G03010201 - G03010202 - G03020101 - G03020102 - G030202 - G03020301 - G03020302 - G03020399 - G030204 - G030299 - G03030101 - G03030102 - G03030199 - G030399 - G0304010101 - G0304010102 - G0304010103 - G0304010104 - G0304010199 - G0304010201 - G0304010202 - G0304010203 - G0304010204 - G0304010299 - G03040201 - G03040202 - G03040299 - G03040301 - G03040302 - G03040303 - G030499 - G03050101 - G0305010201 - G0305010202 - G03050103 - G03050199 - G030502 - G030601 - G030602 - G030603 - G030604 - G030699 - G030701 - G030702 - G030703 - G030704 - G030799 - G0308010101 - G0308010102 - G03080102 - G03080199 - G03080301 - G03080399 - G030804 - G030805 - G030899 - G0380 - G0399 - G0401 - G0402 - G0499 - G05 - G06 - G99 - H010101010101 - H010101010102 - H010101010103 - H010101010104 - H010101010201 - H010101010202 - H010101010203 - H010101010301 - H010101010302 - H010101010303 - H0101010199 - H010101020101 - H010101020102 - H010101020103 - H010101020201 - H010101020202 - H010101020203 - H0101010299 - H010101030101 - H010101030102 - H010101030103 - H010101030201 - H010101030202 - H010101030203 - H010101030301 - H010101030302 - H010101030303 - H0101010399 - H010101040101 - H010101040102 - H010101040201 - H010101040202 - H0101010499 - H010201010101 - H010201010102 - H010201010103 - H010201010201 - H010201010202 - H010201010203 - H010201010301 - H010201010302 - H010201010401 - H010201010402 - H010201010403 - H010201010404 - H010201010501 - H010201010502 - H010201010601 - H010201010602 - H0102010199 - H010201020101 - H010201020102 - H010201020201 - H010201020202 - H010201020203 - H0102010299 - H010202010101 - H010202010102 - H010202010201 - H010202010202 - H010202010301 - H010202010302 - H0102020199 - H010202020101 - H010202020102 - H010202020201 - H010202020202 - H010202020301 - H010202020302 - H010202020401 - H010202020402 - H0102020299 - H0199 - H02010101 - H02010102 - H02010103 - H02010104 - H02010105 - H02010106 - H02010199 - H02010201 - H02010202 - H02010299 - H020180 - H020199 - H020201010101 - H020201010102 - H020201010201 - H020201010202 - H0202010199 - H020201020101 - H020201020102 - H020201020201 - H020201020202 - H0202010299 - H0202010301 - H0202010302 - H0202010399 - H0202010401 - H0202010402 - H0202010499 - H02020199 - H0202020101 - H0202020102 - H0202020201 - H0202020202 - H02020203 - H02020204 - H02020299 - H02020301 - H02020302 - H02020399 - H020280 - H020299 - H020301040101 - H020301040102 - 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Z12069001 - Z12069002 - Z12069003 - Z12069080 - Z12069082 - Z12069085 - Z12069092 - Z12069099 - Z120701 - Z120702 - Z120703 - Z120704 - Z120706 - Z120707 - Z120780 - Z120782 - Z120785 - Z120792 - Z120799 - Z12080101 - Z12080102 - Z12080103 - Z1208010401 - Z1208010402 - Z1208010403 - Z1208010480 - Z1208010482 - Z1208010485 - Z1208010492 - Z1208010499 - Z12080105 - Z12080180 - Z12080182 - Z12080185 - Z12080192 - Z12080199 - Z12080201 - Z12080202 - Z12080203 - Z12080204 - Z12080205 - Z12080280 - Z12080282 - Z12080285 - Z12080292 - Z12080299 - Z12080301 - Z12080303 - Z12080304 - Z12080305 - Z12080380 - Z12080382 - Z12080385 - Z12080392 - Z12080399 - Z12080401 - Z12080402 - Z1208040301 - Z1208040302 - Z1208040380 - Z1208040382 - Z1208040385 - Z1208040392 - Z12080404 - Z12080405 - Z12080406 - Z12080407 - Z12080408 - Z12080409 - Z12080410 - Z12080480 - Z12080482 - Z12080485 - Z12080492 - Z12080499 - Z120899 - Z12090101 - Z12090180 - Z12090182 - Z12090185 - Z12090192 - Z12090201 - Z12090280 - Z12090282 - Z12090285 - Z12090292 - Z12090301 - Z12090380 - Z12090382 - Z12090385 - Z12090392 - Z12099001 - Z12099002 - Z12099003 - Z12099004 - Z12099005 - Z12099006 - Z12099007 - Z12099080 - Z12099082 - Z12099085 - Z12099092 - Z12099099 - Z121001 - Z121002 - Z12100301 - Z12100302 - Z12100303 - Z12100380 - Z12100382 - Z12100385 - Z12100392 - Z12100401 - Z12100480 - Z12100482 - Z12100485 - Z12100492 - Z12100501 - Z12100580 - Z12100582 - Z12100585 - Z12100592 - Z12100601 - Z12100680 - Z12100682 - Z12100685 - Z12100692 - Z12100701 - Z12100702 - Z12100703 - Z12100780 - Z12100782 - Z12100785 - Z12100792 - Z12100801 - Z12100802 - Z12100803 - Z12100880 - Z12100882 - Z12100885 - Z12100892 - Z12100901 - Z12100902 - Z12100980 - Z12100982 - Z12100985 - Z12100992 - Z12101001 - Z12101002 - Z12101003 - Z12101080 - Z12101082 - Z12101085 - Z12101092 - Z12101101 - Z12101102 - Z12101103 - Z12101104 - Z12101105 - Z12101106 - Z12101180 - Z12101182 - Z12101185 - Z12101192 - Z12101199 - Z12101201 - Z12101280 - Z12101282 - Z12101285 - Z12101292 - Z12109001 - Z12109002 - Z12109003 - Z12109004 - Z12109005 - Z12109006 - Z12109007 - Z12109080 - Z12109082 - Z12109085 - Z12109092 - Z12109099 - Z12110101 - Z12110102 - Z12110180 - Z12110182 - Z12110185 - Z12110192 - Z12110199 - Z12119001 - Z12119002 - Z12119003 - Z12119004 - Z12119005 - Z12119006 - Z12119007 - Z12119008 - Z12119009 - Z12119080 - Z12119082 - Z12119085 - Z12119092 - Z12119099 - Z12120101 - Z12120102 - Z12120103 - Z12120104 - Z12120105 - Z12120106 - Z12120107 - Z12120108 - Z12120109 - Z12120110 - Z12120111 - Z12120112 - Z12120113 - Z12120114 - Z12120115 - Z12120116 - Z12120117 - Z12120118 - Z12120119 - Z1212012001 - Z1212012002 - Z1212012003 - Z1212012004 - Z1212012005 - Z1212012080 - Z1212012082 - Z1212012085 - Z1212012092 - Z1212012099 - Z12120121 - Z12120122 - Z12120123 - Z12120124 - Z12120125 - Z12120180 - Z12120182 - Z12120185 - Z12120192 - Z12120199 - Z12120201 - Z12120202 - Z12120203 - Z12120204 - Z1212020501 - Z1212020502 - Z1212020580 - Z1212020582 - Z1212020585 - Z1212020592 - Z1212020599 - Z1212020601 - Z1212020602 - Z1212020680 - Z1212020682 - Z1212020685 - Z1212020692 - Z1212020699 - Z1212020701 - Z1212020702 - Z1212020703 - Z1212020780 - Z1212020782 - Z1212020785 - Z1212020792 - Z1212020799 - Z12120208 - Z12120280 - Z12120282 - Z12120285 - Z12120292 - Z12120299 - Z12129001 - Z12129080 - Z12129082 - Z12129085 - Z12129092 - Z12129099 - Z121301 - Z12130201 - Z12130202 - Z12130280 - Z12130282 - Z12130285 - Z12130292 - Z12130301 - Z12130380 - Z12130382 - Z12130385 - Z12130392 - Z12130401 - Z12130480 - Z12130482 - Z12130485 - Z12130492 - Z12130501 - Z12130502 - Z12130503 - Z12130580 - Z12130582 - Z12130585 - Z12130592 - Z12130599 - Z12139001 - Z12139002 - Z12139003 - Z12139004 - Z12139005 - Z12139006 - Z12139080 - Z12139082 - Z12139085 - Z12139092 - Z12139099 - Z121401 - Z121402 - Z12140301 - Z12140302 - Z12140380 - Z12140382 - Z12140385 - Z12140392 - Z12140401 - Z12140402 - Z12140403 - Z12140404 - Z12140480 - Z12140482 - Z12140485 - Z12140492 - Z12140501 - Z12140580 - Z12140582 - Z12140585 - Z12140592 - Z12149001 - Z12149002 - Z12149003 - Z12149004 - Z12149005 - Z12149006 - Z12149007 - Z12149008 - Z12149009 - Z12149010 - Z12149011 - Z12149080 - Z12149082 - Z12149085 - Z12149092 - Z12149099 - Z12150101 - Z12150102 - Z12150180 - Z12150182 - Z12150185 - Z12150192 - Z12150199 - Z12150201 - Z12150202 - Z12150203 - Z12150280 - Z12150282 - Z12150285 - Z12150292 - Z12159001 - Z12159002 - Z12159003 - Z12159004 - Z12159005 - Z12159006 - Z12159007 - Z12159008 - Z12159009 - Z12159010 - Z12159011 - Z12159080 - Z12159082 - Z12159085 - Z12159092 - Z12159099 - Z12160101 - Z12160180 - Z12160182 - Z12160185 - Z12160192 - Z12160201 - Z12160202 - Z12160280 - Z12160282 - Z12160285 - Z12160292 - Z12160301 - Z12160302 - Z12160303 - Z12160380 - Z12160382 - Z12160385 - Z12160392 - Z12160399 - Z12160401 - Z12160480 - Z12160482 - Z12160485 - Z12160492 - Z121605 - Z12169001 - Z12169002 - Z12169003 - Z12169004 - Z12169080 - Z12169082 - Z12169085 - Z12169092 - Z12169099 - Z121701 - Z121702 - Z121703 - Z12170401 - Z12170402 - Z121780 - Z121799 - Z129003 - Z129004 - Z129005 - Z129006 - Z129007 - Z129009 - Z129010 - Z129011 - Z129012 - Z129013 - Z129017 - Z129080 - Z129082 - Z129085 - Z129092 - Z129099 - Z130101 - Z130102 - Z130103 - Z130104 - Z130105 - Z130106 - Z130107 - Z13019001 - Z13019002 - Z13019099 - Z1302 - Z1399 ReferenceProduct: type: string description: >- UDI-DI related to the current UDI-DI / (EUDAMED ID).\n\nThe reference will be used in order to express the link between a Regulation Device and a Legacy Device (to show that is the same Device). \n\nIn the current phase - relationship will be performed automatically by EUDAMED when the same UDI-DI is used as identifier for the two Devices. Relationship will be only returned when downloading devices from EUDAMED (if applicable). Packages: type: object description: >- Reference to the Container Package Structure associated to the UDI-DI maxItems: 0 minItems: 0 properties: Status: type: string description: >- Status of the Container Package element (On the EU market, Not intended to be placed on the EU market, No longer placed on the EU market) enum: - NO_LONGER_PLACED_ON_THE_MARKET - ON_THE_MARKET PackagingDi: type: string description: Unique identifier of the Package UDI-DI NumberOfItems: type: number description: >- Number of Items in the Package Structure. \n\nUsed when describing the Container Packaging Structure of a Device minimum: 0 Child: type: string description: >- Container Packaging Structure is a hierarchical structure defining how the Device is packaged together for shipping and selling reasons. \nWhen defining the package structure, it starts from the highest element in the structure (highest package in the structure) which contains no more parents and continues till the UDI-DI. For all structures defined , the last element (lowest element in the structure) defined must be the UDI-DI.\n\nThe field stores a link to the child element in the structure (current element being its parent). Field will not be provided for the lowest element - the UDI-DI (as it has no more childs) ChildIssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - GS1 - HIBCC - ICCBBA - IFA required: - NumberOfItems - PackagingDi - Status ClinicalSizes: type: object description: References to the list of Clinical Sizes associated to the UDI-DI properties: ValueText: type: string description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nValue that the Clinical Size can get (when Text is selected as Precision) Value: type: number description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion (either Range, single value or Text), Value and Measuring Unit\n\nValue (Minimum) that the Clinical Size can get (when Value or Range is selected as precision) Maximum: type: number description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nMaximum Value that the Clinical Size can get (when Range is selected as precision) Unit: type: string description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nClinical Size Measure Unit enum: - MU01 - MU02 - MU03 - MU04 - MU05 - MU06 - MU07 - MU08 - MU09 - MU10 - MU100 - MU101 - MU102 - MU103 - MU104 - MU105 - MU106 - MU107 - MU108 - MU109 - MU11 - MU110 - MU111 - MU112 - MU113 - MU114 - MU115 - MU116 - MU117 - MU118 - MU119 - MU12 - MU120 - MU121 - MU122 - MU123 - MU124 - MU125 - MU126 - MU127 - MU128 - MU129 - MU13 - MU130 - MU131 - MU132 - MU133 - MU134 - MU135 - MU136 - MU137 - MU138 - MU139 - MU14 - MU140 - MU141 - MU142 - MU143 - MU144 - MU145 - MU146 - MU147 - MU148 - MU149 - MU15 - MU150 - MU151 - MU152 - MU153 - MU154 - MU156 - MU157 - MU158 - MU159 - MU16 - MU160 - MU161 - MU162 - MU163 - MU164 - MU165 - MU166 - MU167 - MU168 - MU169 - MU17 - MU170 - MU172 - MU173 - MU175 - MU176 - MU18 - MU19 - MU20 - MU21 - MU22 - MU23 - MU24 - MU25 - MU26 - MU27 - MU28 - MU29 - MU30 - MU31 - MU32 - MU33 - MU34 - MU35 - MU36 - MU37 - MU38 - MU39 - MU40 - MU41 - MU42 - MU43 - MU44 - MU45 - MU46 - MU47 - MU48 - MU49 - MU50 - MU51 - MU52 - MU53 - MU54 - MU55 - MU56 - MU57 - MU58 - MU59 - MU60 - MU61 - MU62 - MU63 - MU64 - MU65 - MU66 - MU67 - MU68 - MU69 - MU70 - MU71 - MU72 - MU73 - MU74 - MU75 - MU76 - MU77 - MU78 - MU79 - MU80 - MU81 - MU82 - MU83 - MU84 - MU85 - MU86 - MU87 - MU88 - MU89 - MU90 - MU91 - MU92 - MU93 - MU94 - MU95 - MU96 - MU97 - MU98 - MU99 Precision: type: string description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nClinical Size Precision - mentions how the recording of Data will be performed (as Value, Range or Text is selected) enum: - Range - Text - Value SizeType: type: string description: >- Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nThe Type of Clinical Size (example : length, width, etc.) enum: - CST1 - CST10 - CST11 - CST12 - CST13 - CST14 - CST15 - CST16 - CST17 - CST18 - CST19 - CST2 - CST20 - CST21 - CST22 - CST23 - CST24 - CST25 - CST26 - CST27 - CST28 - CST29 - CST3 - CST30 - CST31 - CST32 - CST33 - CST34 - CST35 - CST36 - CST37 - CST38 - CST39 - CST4 - CST40 - CST41 - CST42 - CST43 - CST44 - CST45 - CST46 - CST47 - CST48 - CST49 - CST5 - CST50 - CST51 - CST52 - CST53 - CST54 - CST55 - CST56 - CST57 - CST58 - CST59 - CST6 - CST60 - CST61 - CST62 - CST63 - CST65 - CST66 - CST67 - CST7 - CST8 - CST9 required: - Precision - SizeType ProductionIdentifier: type: string description: >- Reference to the Types of UDI-PI (production Identifiers) applicable for the current Device (UDI-DI). Defines the way the production is controled enum: - BATCH_NUMBER - EXPIRATION_DATE - MANUFACTURING_DATE - SERIALISATION_NUMBER - SOFTWARE_VERSION MFActorCode: type: string DeviceModel: type: string Reprocessed: type: boolean description: >- Property defines if the Device is a Reprocessesed single use device or not DeviceImplantableExceptions: type: boolean ReqSterilizatonPriorUse: type: boolean description: >- Property defines if the UDI-DI needs to be sterilised before use or not MaterialText: type: string description: Name of the Material of the device. Device: type: string description: >- The UDI-DI is a unique numeric or alphanumeric code specific to a device and that is also used as the 'access key' to information stored in a UDI database AdditionalTradeNames: type: object description: >- Device Trade Name assigned to the UDI-DI\n\nTrade names can be provided if applicable for the device. Several Trade- Names can be provided for the Device in the same language or in different languages maxItems: 0 minItems: 0 properties: AdditionalTradeNameLanguage: type: string enum: - ANY - BG - CS - DA - DE - EL - EN - ES - ET - FI - FR - GA - HR - HU - IS - IT - LT - LV - MT - NL - 'NO' - PL - PT - RO - SK - SL - SV - TR AdditionalTradeName: type: string description: >- Device Trade Name assigned to the UDI-DI\n\nTrade names can be provided if applicable for the device. Several Trade- Names can be provided for the Device in the same language or in different languages required: - AdditionalTradeName - AdditionalTradeNameLanguage ReferenceNumber: type: string description: Property stores the Reference or Catalogue Number of the Device Sterile: type: boolean description: Property defines if the UDI-DI is labeled as Sterile or not BaseQuantity: type: number description: The base quantity in which the Device is provided minimum: 0 SecondaryDi: type: string description: >- Secondary UDI DI Code - reference to the Secondary UDI-DI registered for the current UDI-DI . \n\nAdditional DI associated to this UDI-DI. \nOnly one Secondary UDI-DI (Additional UDI-DI) can be associated to a UDI-DI DirectMarkingDiIssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - '0' - GS1 - HIBCC - ICCBBA - IFA DeviceGroupAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of Basic UDIs enum: - GS1 - HIBCC - ICCBBA - IFA Storage: type: object description: >- References the Storage and Handling Conditions associated to the Device (UDI-DI) properties: StorageType: type: string description: >- Storage and handling Conditions specified on the Label of the Device have to be registered in EUDAMED - if applicable. \n\nField stores the Type of Storage and Handling Conditions. Field is Applicable only when the type of Conditions for Use have the Type Storage / handling Conditions, being required in this case. enum: - SHC001 - SHC002 - SHC003 - SHC004 - SHC005 - SHC006 - SHC007 - SHC008 - SHC009 - SHC010 - SHC012 - SHC013 - SHC014 - SHC015 - SHC016 - SHC017 - SHC018 - SHC019 - SHC021 - SHC022 - SHC023 - SHC024 - SHC025 - SHC033 - SHC035 - SHC036 - SHC037 - SHC038 - SHC042 - SHC044 - SHC045 - SHC046 - SHC047 - SHC099 StorageConditionLocalized: type: string description: >- Comments or description associated to the values selected form the Storage or handling Conditions or Critical warnings required: - StorageType DirectMarkingDi: type: string description: >- Direct Marking UDI-DI - is the DI with which the Device (UDI-DI) is marked directly\n\nField is mandatory when the Device is directly marked ( Direct Marking = YES). The value of the field is a DI - either the current UDI-DI (of the current device) or a different UDI-DI AdditionalDeviceDescriptions: type: object description: >- Additional Product Description.\n\nAdditional Product Description is required for System or Procedure Packs or for Standard Devices being marked as System or Procedure Packs (as a Device in themselvs) maxItems: 0 minItems: 0 properties: AdditionalDeviceDescriptionLanguage: type: string enum: - BG - CS - DA - DE - EL - EN - ES - ET - FI - FR - GA - HR - HU - IS - IT - LT - LV - MT - NL - 'NO' - PL - PT - RO - SK - SL - SV - TR AdditionalDeviceDescription: type: string required: - AdditionalDeviceDescription - AdditionalDeviceDescriptionLanguage AnimalTissuesCells: type: boolean NumberOfReuses: type: number description: >- Property defines the Maximum Number of reuses applicable for the Device.\n\nFor an undefined number of reuses, enter -1, for single use devices enter 0 ApplicableLegislation: type: string enum: - MDR ContainsLatex: type: boolean description: Property defines if the Device contains latex into it`s composition MarketInfos: type: object description: >- Reference to the list of Countries were the device has been made available maxItems: 0 minItems: 0 properties: StartDate: type: string format: yyyy-MM-dd description: >- Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product.\n\nField stores details about the Start Date when the Device is made available on the marked Country: type: string description: >- Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product.\n\nField stores details about the Country were the Device is made available on the market enum: - AT - BE - BG - CY - CZ - DE - DK - EE - EL - ES - FI - FR - HR - HU - IE - IS - IT - LI - LT - LU - LV - MT - NL - 'NO' - PL - PT - RO - SE - SI - SK - TR - XI OriginalPlacedOnTheMarket: type: boolean description: >- Defines the Country were the device has been placed on the Market (Member State in which the device is to or has been placed on the market in the Union) EndDate: type: string format: yyyy-MM-dd description: >- Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product.\n\nField stores details about the End Date when the Device is made available on the marked required: - Country - OriginalPlacedOnTheMarket DeviceImplantable: type: boolean ProductDesignerActorContactDetails: type: string description: >- For the Product Designer Organisation Public Contact details need to be provided ProductDesignerActorCode: type: string description: >- Details of the Product Designer (Original Manufacturer) who Manufactured (produced) and Designed the Device.\n\nAn original design manufacturer (ODM) is a company that designs and manufactures a product, as specified, that is eventually rebranded by another firm for sale. \n\nSRN of the natural or legal person who designed and manufactured the device. Reference to a Manufacturer present in EUDAMED SubmissionExcluded: type: boolean description: >- Indicates that a product is excluded from submission to the regulatory authority. ActiveDevice: type: boolean Website: type: string description: >- Manufacturer`s website where additional information about the device (UDI-DI) are available SecondaryDiAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - '0' - GS1 - HIBCC - ICCBBA - IFA ProcedurePackDevice: type: boolean DeviceHasMeasuringFunction: type: boolean SystemDevice: type: boolean MedicinalProductCheck: type: boolean HumanProductCheck: type: boolean UnitOfUseDiIssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - '0' - GS1 - HIBCC - ICCBBA - IFA RiskClass: type: string enum: - CLASS_I - CLASS_IIA - CLASS_IIB - CLASS_III ProductDesignerActorOrganizationName: type: string description: Name of the Organisation IssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - GS1 - HIBCC - ICCBBA - IFA Material: type: string description: Material number of the device. CommercialDistributionStatus: type: string description: >- Status of the Device (On the EU market, Not intended to be placed on the EU Market, No longer placed on the EU market). enum: - NOT_INTENDED_FOR_EU_MARKET - NO_LONGER_PLACED_ON_THE_MARKET - ON_THE_MARKET DeviceIntendedToAdministerMedicine: type: boolean ProductDesignerActorGeographicAddress: type: string description: Adress of the Product Desginer Organisation NonMedicalDeviceType: type: string description: >- Field stores the reference to the Intended purpose other than medical of the Device (UDI-DI).\n\nField stores the values regarding the Intended purpose of the Device other the medical one`s as they are descubed in the Annex XVI of MDR Regulation enum: - BRAIN_ELECTROSTIMULATION - CONTACT_LENSES - EMR - EQUIPMENT_FOR_ADDIPOSE_TISSUE - FILLING_BY_INJECTION - PRODUCT_IN_BODY Warnings: type: object description: >- References the Critical warnings associated to the Device (UDI-DI) maxItems: 0 minItems: 0 properties: WarningCommentLocalized: type: string description: >- Comments or description associated to the values selected for the Critical warnings Type: type: string description: >- Storage and handling Conditions and Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be registered in EUDAMED - if applicable. \n\nField stores the Type of Critical Warnings or Contra-Indications, being required in this case enum: - CW001 - CW006 - CW007 - CW008 - CW009 - CW010 - CW011 - CW012 - CW013 - CW014 - CW015 - CW016 - CW017 - CW018 - CW020 - CW022 - CW023 - CW024 - CW025 - CW026 - CW027 - CW028 - CW029 - CW030 - CW031 - CW032 - CW035 - CW036 - CW037 - CW038 - CW039 - CW040 - CW041 - CW042 - CW043 - CW044 - CW045 - CW046 - CW047 - CW048 - CW049 - CW050 - CW051 - CW052 - CW053 - CW054 - CW055 - CW056 - CW057 - CW058 - CW059 - CW060 - CW061 - CW062 - CW063 - CW064 - CW065 - CW066 - CW067 - CW068 - CW069 - CW070 - CW071 - CW072 - CW073 - CW074 - CW075 - CW076 - CW077 - CW078 - CW079 - CW080 - CW081 - CW082 - CW083 - CW084 - CW085 - CW086 - CW087 - CW088 - CW089 - CW090 - CW091 - CW092 - CW093 - CW094 - CW095 - CW096 - CW097 - CW098 - CW099 - CW100 - CW101 - CW102 - CW103 - CW104 - CW105 - CW106 - CW107 - CW108 - CW109 - CW110 - CW111 - CW112 - CW113 - CW114 - CW115 - CW116 - CW117 - CW118 - CW119 - CW120 - CW121 - CW122 - CW123 - CW124 - CW125 - CW126 - CW127 - CW128 - CW129 - CW130 - CW131 - CW132 - CW133 - CW134 - CW135 - CW136 - CW137 - CW138 - CW139 - CW140 - CW141 - CW142 - CW143 - CW144 - CW146 - CW147 - CW148 - CW149 - CW150 - CW151 - CW152 - CW153 - CW154 - CW155 - CW156 - CW157 - CW158 - CW159 - CW160 - CW161 - CW162 - CW163 - CW164 - CW165 - CW166 - CW167 - CW168 - CW169 - CW170 - CW171 - CW172 - CW173 - CW175 - CW176 - CW177 - CW178 - CW179 - CW180 - CW181 - CW182 - CW183 - CW184 - CW185 - CW186 - CW187 - CW188 - CW189 - CW190 - CW191 - CW192 - CW193 - CW194 - CW195 - CW196 - CW197 - CW198 - CW199 - CW201 - CW202 - CW203 - CW206 - CW207 - CW208 - CW209 - CW210 - CW211 - CW212 - CW213 - CW216 - CW217 - CW218 - CW219 - CW220 - CW221 - CW223 - CW224 - CW225 - CW226 - CW254 - CW255 - CW257 - CW258 - CW259 - CW260 - CW261 - CW262 - CW263 - CW264 - CW265 - CW266 - CW267 - CW268 - CW269 - CW270 - CW271 - CW272 - CW273 - CW274 - CW275 - CW276 - CW277 - CW278 - CW279 - CW280 - CW281 - CW282 - CW283 - CW284 - CW285 - CW286 - CW287 - CW288 - CW289 - CW290 - CW291 - CW292 - CW293 - CW294 - CW295 - CW296 - CW297 - CW298 - CW299 - CW300 - CW301 - CW302 - CW303 - CW304 - CW305 - CW306 - CW307 - CW308 - CW309 - CW310 - CW311 - CW312 - CW313 - CW314 - CW315 - CW316 - CW317 - CW318 - CW319 - CW320 - CW321 - CW322 - CW323 - CW324 - CW325 - CW326 - CW327 - CW328 - CW329 - CW330 - CW331 - CW332 - CW333 - CW334 - CW335 - CW336 - CW337 - CW338 - CW339 - CW340 - CW341 - CW342 - CW343 - CW344 - CW345 - CW346 - CW347 - CW348 - CW349 - CW350 - CW351 - CW352 - CW353 - CW354 - CW355 - CW356 - CW357 - CW358 - CW359 - CW360 - CW361 - CW362 - CW363 - CW364 - CW365 - CW366 - CW367 - CW368 - CW369 - CW370 - CW371 - CW372 - CW373 - CW374 - CW375 - CW376 - CW377 - CW378 - CW379 - CW380 - CW381 - CW382 - CW383 - CW384 - CW385 - CW386 - CW387 - CW388 - CW389 - CW390 - CW391 - CW392 - CW393 - CW394 - CW395 - CW396 - CW397 - CW398 - CW399 - CW400 - CW401 - CW402 - CW403 - CW404 - CW405 - CW406 - CW407 - CW408 - CW409 - CW410 - CW411 - CW412 - CW413 - CW414 - CW415 - CW416 - CW417 - CW418 - CW419 - CW420 - CW421 - CW422 - CW423 - CW424 - CW425 - CW426 - CW427 - CW428 - CW429 - CW430 - CW431 - CW432 - CW433 - CW434 - CW435 - CW436 - CW437 - CW438 - CW439 - CW440 - CW441 - CW442 - CW443 - CW444 - CW445 - CW446 - CW447 - CW448 - CW449 - CW450 - CW451 - CW452 - CW453 - CW454 - CW455 - CW456 - CW457 - CW458 - CW459 - CW460 - CW461 - CW462 - CW463 - CW464 - CW465 - CW466 - CW999 required: - Type ARActorCode: type: string ClinicalInvestigations: type: object properties: NonEUApplicableCountries: type: string enum: - AD - AE - AF - AG - AI - AL - AM - AO - AQ - AR - AS - AU - AW - AX - AZ - BA - BB - BD - BF - BH - BI - BJ - BL - BM - BN - BO - BQ - BR - BS - BT - BV - BW - BY - BZ - CA - CC - CD - CF - CG - CI - CK - CL - CM - CN - CO - CR - CU - CV - CW - CX - DJ - DM - DO - DZ - EC - EG - EH - ER - ET - FJ - FK - FM - FO - GA - GB - GD - GE - GF - GG - GH - GI - GL - GM - GN - GP - GQ - GS - GT - GU - GW - GY - HK - HM - HN - HT - ID - IL - IM - IN - IO - IQ - IR - JE - JM - JO - JP - KE - KG - KH - KI - KM - KN - KP - KR - KW - KY - KZ - LA - LB - LC - LK - LR - LS - LY - MA - MC - MD - ME - MF - MG - MH - MK - ML - MM - MN - MO - MP - MQ - MR - MS - MU - MV - MW - MX - MY - MZ - NA - NC - NE - NF - NG - NI - NP - NR - NU - NZ - OM - PA - PE - PF - PG - PH - PK - PM - PN - PR - PS - PW - PY - QA - RE - RS - RU - RW - SA - SB - SC - SD - SG - SH - SJ - SL - SM - SN - SO - SR - ST - SV - SX - SY - SZ - TC - TD - TF - TG - TH - TJ - TK - TL - TM - TN - TO - TT - TV - TW - TZ - UA - UG - UM - US - UY - UZ - VA - VC - VE - VG - VI - VN - VU - WF - WS - YE - YT - ZA - ZM - ZW Reference: type: string DeviceName: type: string required: - ApplicableLegislation - BaseQuantity - CommercialDistributionStatus - ContainsLatex - Device - DeviceGroup - IssuingAgency - MDN - MarketInfos - Material - NumberOfReuses - OrgUnit - ProcedurePackDevice - ProductionIdentifier - ReferenceNumber - Reprocessed - ReqSterilizatonPriorUse - Sterile - SubmissionExcluded - SystemDevice DEVICE_GROUP_EU_UDI_MDR: type: object properties: OrgUnit: type: string Certificates: type: object description: >- References the Device Certificate Informations related to the Basic UDI-DI.\n\nWhen registering the Device , Device Certificate information is required when the Regulation Device is covered by a Product Certificate (required to provide the Notified Body and optional Certificate Number and Certificate Date) properties: CertificateType: type: string description: >- When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.\n\nProperty defines the type of Product Certificate associate with the Device enum: - MDR_PRODUCT_VERIFICATION - MDR_QUALITY_ASSURANCE - MDR_QUALITY_MANAGEMENT_SYSTEM - MDR_TECHNICAL_DOCUMENTATION - MDR_TYPE_EXAMINATION NotifiedBodyActorCode: type: string description: >- When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.\n\nProperty stores the reference to the Notified Body that issued the Product Certificate enum: - '0044' - '0050' - '0051' - '0068' - '0123' - '0124' - '0197' - '0297' - '0318' - '0333' - '0344' - '0373' - '0425' - '0426' - '0459' - '0476' - '0477' - '0482' - '0483' - '0494' - '0537' - '0546' - '0598' - '0633' - '1011' - '1023' - '1282' - '1304' - '1370' - '1383' - '1434' - '1639' - '1912' - '1936' - '1984' - '2265' - '2274' - '2292' - '2409' - '2443' - '2460' - '2696' - '2764' - '2797' - '2803' - '2862' - '2962' - '2975' - '3022' - '3033' CertificateNumber: type: string description: >- When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.\n\nProperty stores the Certificate Number of the Product Certificate CertificateRevisionNumber: type: string description: >- When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.\n\nProperty stores the Certificate Revision Number of the Product Certificate required: - CertificateType - NotifiedBodyActorCode DeviceGroup: type: string description: >- Device Identifier code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.)\n\nThe Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity ActiveDevice: type: boolean description: >- Property defines if the Basic UDI-DI corresponds to an Active device or not.\n\n'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. \n\nDevices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device DeviceReusableSurgicalInstrument: type: boolean description: >- Property defines if the Device is a Reusable Surgical Instrument or not.\n\n'Reusable surgical instrument' means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the Manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. \n\nIn case of Devices being marked as Implantable (field "Implantable" has value "True" )field Reusable Surgical Instruments has by default value "False" SpecialDeviceType: type: string description: >- Property defines if the Device is a Special Device Type anf if so , the type of Special device Type. \n\nIn case the Device is a Standard Device having the option System or Procedure Pack (which is a Device in itself) or a System or Procedure Pack - field is not supplied enum: - '0' - MDR_MADE_TO_ORDER - MDR_ORTHOPEDIC - MDR_READY_MADE_SPECTACLES - MDR_RIGID_GAS_PERMEABLE - MDR_SOFTWARE - MDR_SPECTACLES_FRAMES - MDR_SPECTACLES_LENSES - MDR_STANDARD_SOFT_CONTACT_LENSES HumanTissuesCells: type: boolean description: >- Property defines if the Device has presence of human tissues or cells or their derivates ProcedurePackDevice: type: boolean description: >- Property defines if the Basic UDI-DI is refering to a Procedure pack which is a Device in itself (in accordance with the Art. 22(4) MDR ).\n\nProperty is a applicable for Standard Devices (not Systems or Procedure Packs)\n\nOption Procedure pack which is a Device in itself is applicable only in case of MDR Devices DeviceHasMeasuringFunction: type: boolean description: Property defines if the Device has a Measuring Function or not SystemDevice: type: boolean description: >- Property defines if the Basic UDI-DI is refering to a System which is a Device in itself.\n\nProperty is a applicable for Standard Devices (not Systems or Procedure Packs)\n\nOption System which is a Device in itself is applicable only in case of MDR Devices MFActorCode: type: string description: SRN of the Manufacturer that registers the Device MedicinalProductCheck: type: boolean description: >- Defines if the Device containes substances which may be considered medicinal product DeviceModel: type: string description: >- Information allowing the identification of the device - Device Model. \n\nAt least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI HumanProductCheck: type: boolean description: >- Defines if the Device containes substances which may be considered medicinal product derived from human blood or plasma DeviceImplantableExceptions: type: boolean description: >- Property defines if the registered Device is 'sutures', 'staples', 'dental fillings', 'dental braces', 'tooth crowns', 'screws', 'wedges', 'plates wires', 'pins', 'clips and connectors' (these defines are exempted from the regulation imposed to implantable devices).\n\nProperty is applicable only for Devices having Risk Class II b and having the property 'Implantable' marked RiskClass: type: string description: >- Risk Class of the Device associated with the Basic UDI-DI.\n\nDevice Risk Class is dependent directly on the Applicable Legislation of the Device enum: - CLASS_I - CLASS_IIA - CLASS_IIB - CLASS_III UdiDis: type: object properties: MaterialText: type: string description: Name of the Material of the device. Material: type: string description: Material number of the device. UdiDi: type: string required: - UdiDi DeviceGroupAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of Basic UDIs enum: - GS1 - HIBCC - ICCBBA - IFA DeviceIntendedToAdministerMedicine: type: boolean description: >- Property defines if the Device is intended to administer or remove medicinal product AnimalTissuesCells: type: boolean description: >- Property defines if the Device has presence of animal tissues or cells or their derivates ApplicableLegislation: type: string description: >- Applicable Legislation of the Device.\n\nThe device can have only one Applicable Legislation. Either a Regulation value can be selected/provided (MDR or IVDR) or a Directive Regulation value (MDD, AIMDD or IVDD) - in the case of Directive Devices enum: - MDR DeviceImplantable: type: boolean description: >- Property defines if the Basic UDI-DI corresponds to a device that is Implantable or not.\n\nAny device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.\n\nIn case of Devices having the Risck Class " Class I " field Implantable has by default value "False" ARActorCode: type: string description: >- The SRN of the Authorised Representative associated with the Basic UDI-DI.\n\nFor Manufacturers which are not established in the Union (NonEU Manufacturers) providing the Authorised Representative for the Basic UDI-DI is required ClinicalInvestigations: type: object description: >- References the Clinical Investigation Link, storing the details of Clinical Investigations associated to the Basic UDI-DI properties: NonEUApplicableCountries: type: string description: >- List of Countries were the Clinical Investigation has been performed.\n\nField is optional and can be provided only for Clinical Investigations performed Outside EU (Non EU Countries only).\n\nIf provided, the Clinical Investigation is considered to be NonEU Clinical Investigation enum: - AD - AE - AF - AG - AI - AL - AM - AO - AQ - AR - AS - AU - AW - AX - AZ - BA - BB - BD - BF - BH - BI - BJ - BL - BM - BN - BO - BQ - BR - BS - BT - BV - BW - BY - BZ - CA - CC - CD - CF - CG - CI - CK - CL - CM - CN - CO - CR - CU - CV - CW - CX - DJ - DM - DO - DZ - EC - EG - EH - ER - ET - FJ - FK - FM - FO - GA - GB - GD - GE - GF - GG - GH - GI - GL - GM - GN - GP - GQ - GS - GT - GU - GW - GY - HK - HM - HN - HT - ID - IL - IM - IN - IO - IQ - IR - JE - JM - JO - JP - KE - KG - KH - KI - KM - KN - KP - KR - KW - KY - KZ - LA - LB - LC - LK - LR - LS - LY - MA - MC - MD - ME - MF - MG - MH - MK - ML - MM - MN - MO - MP - MQ - MR - MS - MU - MV - MW - MX - MY - MZ - NA - NC - NE - NF - NG - NI - NP - NR - NU - NZ - OM - PA - PE - PF - PG - PH - PK - PM - PN - PR - PS - PW - PY - QA - RE - RS - RU - RW - SA - SB - SC - SD - SG - SH - SJ - SL - SM - SN - SO - SR - ST - SV - SX - SY - SZ - TC - TD - TF - TG - TH - TJ - TK - TL - TM - TN - TO - TT - TV - TW - TZ - UA - UG - UM - US - UY - UZ - VA - VC - VE - VG - VI - VN - VU - WF - WS - YE - YT - ZA - ZM - ZW Reference: type: string description: >- When registering the Device - where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation must be provided.\n\nField stores the Clinical Investigation Number provided by the user when the Clinical Investigation is not registered in EUDAMED required: - Reference DeviceName: type: string description: >- Information allowing the identification of the device - Device Name. \n\nAt least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI required: - ActiveDevice - AnimalTissuesCells - ApplicableLegislation - DeviceGroup - DeviceGroupAgency - DeviceHasMeasuringFunction - DeviceImplantable - DeviceIntendedToAdministerMedicine - DeviceReusableSurgicalInstrument - HumanProductCheck - HumanTissuesCells - MFActorCode - MedicinalProductCheck - OrgUnit - ProcedurePackDevice - RiskClass - SystemDevice ValidationResponse: type: object properties: status: type: string description: Overall status of the validation message: type: string description: Validation message deviceErrors: type: array description: Validation errors related to the device (DI) items: $ref: '#/components/schemas/ValidationError' deviceGroupErrors: type: array description: Validation errors related to the device group (BUDI) items: $ref: '#/components/schemas/ValidationError' ValidationError: type: object properties: path: type: string description: (JSON)-Path to the field the validation error is related to message: type: string description: Validation message ruleId: type: string description: Validation rule identifier securitySchemes: ApiKeyAuth: type: apiKey name: Authorization in: header ````