> ## 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 IVDR Submit > Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). ## OpenAPI ````yaml post /api/v1/submit/EU_UDI_IVDR openapi: 3.1.0 info: title: OpenAPI definition version: v0 servers: - url: https://api-preview.udiconnect.io description: P36 UDI Hub API Server security: - ApiKeyAuth: [] paths: /api/v1/submit/EU_UDI_IVDR: post: tags: - Submission summary: EUDAMED IVDR Submit 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: device: IssuingAgency: GS1 Device: '00389524361706' DeviceGroup: 439990216407HD BaseQuantity: 1 CommercialDistributionStatus: ON_THE_MARKET ProductionIdentifier: - BATCH_NUMBER ReferenceNumber: 37588-474 MDN: - A0101010101 NumberOfReuses: -1 Sterile: false ReqSterilizatonPriorUse: true NewDevice: false MarketInfos: - Country: DE OriginalPlacedOnTheMarket: true deviceGroup: DeviceGroupAgency: GS1 DeviceGroup: 439990216407HD ApplicableLegislation: IVDR MFActorCode: DE-MF-000001723 DeviceName: p36 Test Device Name RiskClass: CLASS_A AnimalTissuesCells: false HumanTissuesCells: false DeviceIntendedForSelfTesting: false DeviceIntendedForNearPatientTesting: false DeviceCompanionDiagnostics: false DeviceIntendedProfessionalTesting: false KitDevice: false Instrument: false Reagent: false DeviceContainsMicrobialSubstances: false Full Data Example: description: Full Data Example value: device: IssuingAgency: GS1 Device: '00393719305468' Material: 123456-001 MaterialText: p36 Test Device OrgUnit: Bad Hersfeld DeviceGroup: 439990297846MA BaseQuantity: 1 DirectMarkingDiIssuingAgency: GS1 DirectMarkingDi: '00329299513788' CommercialDistributionStatus: ON_THE_MARKET ProductionIdentifier: - MANUFACTURING_DATE - BATCH_NUMBER ReferenceNumber: 37588-474 SecondaryDiAgency: HIBCC SecondaryDi: +A999P36TESTDEVICEXX UnitOfUseDiIssuingAgency: GS1 UnitOfUseDi: '00355089698137' MDN: - A0101010101 Website: www.p36.io NumberOfReuses: -1 Sterile: false ReqSterilizatonPriorUse: true NewDevice: false ProductDesignerName: p36 GmbH ProductDesignerStreet: Hof Meisebach ProductDesignerStreetNumber: '1' ProductDesignerCity: Bad Hersfeld ProductDesignerPostCode: '36251' ProductDesignerCountry: DE ProductDesignerMail: udi-regulatory@p36.io ProductDesignerPhone: +49 (0)6621 968282-200 ProductDesignerActorCode: DE-MF-000001723 Packages: - PackagingDi: '00359412962322' NumberOfItems: 10 Child: '00363932443216' ChildIssuingAgency: GS1 Status: ON_THE_MARKET MarketInfos: - Country: DE StartDate: '2021-01-01' EndDate: '2023-12-31' OriginalPlacedOnTheMarket: true AdditionalTradeNames: - AdditionalTradeName: p36 Test Device AdditionalTradeNameLanguage: EN AdditionalDeviceDescriptions: - AdditionalDeviceDescription: p36 Test Device AdditionalDeviceDescriptionLanguage: EN Storage: - StorageType: SHC99 StorageConditionLocalized: - language: EN value: Special Storage Condition Warnings: - Type: CW999 WarningCommentLocalized: - language: EN value: Warning Comment deviceGroup: DeviceGroupAgency: GS1 DeviceGroup: 439990297846MA ApplicableLegislation: IVDR OrgUnit: Bad Hersfeld MFActorCode: CH-MF-000009999 ARActorCode: DE-MF-000001723 DeviceName: p36 Test Device Name RiskClass: CLASS_A DeviceModel: p36 Test Device Name AnimalTissuesCells: false HumanTissuesCells: false SpecialDeviceType: IVDR_SOFTWARE Certificates: - CertificateNumber: '1234567890' CertificateRevisionNumber: '1' NotifiedBodyActorCode: '0123' CertificateType: IVDR_TYPE_EXAMINATION DeviceIntendedForSelfTesting: false DeviceIntendedForNearPatientTesting: false DeviceCompanionDiagnostics: false DeviceIntendedProfessionalTesting: false KitDevice: false Instrument: false Reagent: false DeviceContainsMicrobialSubstances: false ClinicalInvestigations: - Reference: 123-ABC-456 NonEUApplicableCountries: US required: true responses: '200': description: Submission Successful content: application/json: schema: $ref: '#/components/schemas/SubmissionSuccessResponse' examples: Submission Successful: description: Submission processed successfully value: agency: EC requestId: string modelInformation: string status: SUCCESS statusText: Submission successfully validated and accepted '400': description: Submission Validation Error content: application/json: schema: type: object oneOf: - $ref: '#/components/schemas/SubmissionValidationErrorResponse' - $ref: >- #/components/schemas/SubmissionRequestValidationErrorResponse 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 Submission Request Validation Error: description: Submission request validation error value: agency: EC requestId: string modelInformation: string status: INVALID_REQUEST statusText: request data is invalid according to the authority rules reasons: - No actor code was provided '409': description: Submission Blocked content: application/json: schema: $ref: '#/components/schemas/SubmissionBlockedResponse' examples: Submission Blocked: description: >- Submission blocked - Request cannot be processed due to business rules 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 content: application/json: schema: $ref: '#/components/schemas/SubmissionTechnicalErrorResponse' examples: Internal Server Error: description: Technical processing error - Internal server error occurred value: timestamp: string status: 500 error: Internal Server Error message: string components: schemas: SubmissionRequest: type: object properties: actorCode: type: string securityToken: type: string authorizedRepresentativeCode: type: string device: $ref: '#/components/schemas/DEVICE_EU_UDI_IVDR' description: required for all EC submissions deviceGroup: $ref: '#/components/schemas/DEVICE_GROUP_EU_UDI_IVDR' 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 - INVALID_REQUEST statusText: type: string description: Submission response status text readOnly: true SubmissionValidationErrorResponse: type: object 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 validationResult: $ref: '#/components/schemas/ValidationResponse' description: Detailed information about the validation failures status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED - INVALID_REQUEST statusText: type: string description: Submission response status text readOnly: true SubmissionRequestValidationErrorResponse: 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 reasons: type: array description: List of reasons why the request in not accepted items: type: string status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED - INVALID_REQUEST statusText: type: string description: Submission response status text readOnly: true 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 reasons: type: array description: List of reasons why the submission was blocked items: type: string status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED - INVALID_REQUEST statusText: type: string description: Submission response status text readOnly: true 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 reasons: type: array description: List of errors that occurred during submission processing items: type: string status: type: string description: Submission response status enum: - INTERNAL_ERROR - SUCCESS - BLOCKED - VALIDATION_FAILED - INVALID_REQUEST statusText: type: string description: Submission response status text readOnly: true DEVICE_EU_UDI_IVDR: type: object properties: OrgUnit: type: string ProductDesignerName: type: string description: Name of the Organisation 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 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 DeviceGroup: type: string description: Reference to the Basic UDI-DI to which the Device is associated Website: type: string description: >- Manufacturer`s website where additional information about the device (UDI-DI) are available ProductDesignerPostCode: type: string description: >- Adress of the Product Desginer Organisation\n\nA geographical address postal code ProductDesignerStreetNumber: type: string description: >- Adress of the Product Desginer Organisation\n\nA geographical address street number ProductDesignerStreet: type: string description: >- Adress of the Product Desginer Organisation\n\nA geographical address street name SecondaryDiAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - GS1 - HIBCC - ICCBBA - IFA 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 - H020301040199 - H020301040201 - H020301040202 - H020301040299 - H0203010499 - H020301050101 - H020301050102 - H020301050199 - H020301050201 - H020301050202 - H020301050299 - H02030106 - H02030199 - H0203020101 - H0203020199 - H02030299 - H020303 - H020380 - H020399 - H020401 - H020402 - H020403 - H0299 - H03010101 - H03010102 - H03010104 - H03010105 - H03010199 - H03010201 - H03010202 - H030199 - H03020101 - H03020103 - H03020199 - H030299 - H03030101 - H03030102 - H03800101 - H03800102 - H038099 - H0399 - H90010101 - H90010102 - H900102 - H900199 - H90020101 - H90020102 - H90020103 - H90020199 - H900202 - H900203 - H900299 - H900301 - H900302 - H900303 - H900304 - H900305 - H900399 - H9005 - H9006 - H9007 - H900801 - H900802 - H900899 - H9080 - H9099 - J01010101 - J01010102 - J01010201 - J01010202 - J01010301 - J01010302 - J01010401 - J010105 - J010180 - J010199 - J010201 - J010280 - J010299 - J01030101 - J01030102 - J01030103 - J010380 - J010399 - J010401 - J010480 - J010499 - J01050101 - J01050201 - J01050301 - J010504 - J010580 - J010599 - J0106 - J010701 - J010702 - J010780 - J010782 - J010792 - J010799 - J019001010101 - J019001010102 - J0190010102 - J0190010103 - J0190010104 - J0190010105 - J019001020101 - J019001020102 - J019001020199 - J0190010202 - J01900180 - J01900199 - J01900203 - J01900280 - J01900282 - J01900285 - J01900292 - J019003 - J019004 - J019005 - J019099 - J02010101 - J02010102 - J020102 - J020180 - J020199 - J020201 - J02020201 - J02020202 - J020203 - J020280 - J020299 - J020301 - 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L1199 - L1201 - L1202 - L1203 - L1204 - L1205 - L1206 - L1207 - L1208 - L1209 - L1210 - L1211 - L1212 - L1213 - L1214 - L1215 - L1216 - L1217 - L1218 - L1280 - L1299 - L1301 - L1302 - L1303 - L1304 - L1305 - L1306 - L1307 - L1399 - L14010101 - L14010102 - L14010103 - L14010199 - L14010201 - L14010202 - L14010203 - L14010204 - L14010205 - L14010206 - L14010299 - L140201 - L140202 - L140203 - L140204 - L140205 - L140206 - L140299 - L140301 - L140399 - L140401 - L14040201 - L14040202 - L14040203 - L14040204 - L14040299 - L140499 - L14050101 - L14050102 - L14050103 - L14050199 - L140502 - L140503 - L140599 - L140601 - L140602 - L149001 - L149002 - L149003 - L149004 - L149005 - L149006 - L149007 - L149008 - L149009 - L149010 - L149011 - L149012 - L149013 - L149099 - L150101 - L150102 - L150103 - L150201 - L150202 - L150299 - L150301 - L150302 - L150399 - L1504 - L1505 - L1506 - L150701 - L150702 - L150703 - L150704 - L150705 - L150799 - L1508 - L159001 - L159002 - L159003 - L159004 - L159005 - L15900601 - L15900602 - L15900699 - L159007 - L15900801 - L15900899 - L159009 - L159010 - L15901101 - L15901102 - L15901199 - L159012 - L159013 - L159014 - L159015 - L159016 - L159017 - L159018 - L159019 - L159099 - L160101 - L160199 - L160201 - L160202 - L160299 - L1699 - L17010101 - L17010199 - L170102 - L170201 - L170202 - L170203 - L170299 - L1703 - L170401 - L170402 - L170499 - L1705 - L1706 - L1707 - L1708 - L1709 - L1710 - L1711 - L1712 - L1713 - L1714 - L1715 - L179001 - L179002 - L17900301 - L17900399 - L179004 - L179005 - L1799 - L180101 - L180102 - L180201 - L180202 - L180301 - L180302 - L180401 - L180402 - L180501 - L180502 - L180601 - L180602 - L180701 - L180702 - L180801 - L180802 - L180901 - L180902 - L181001 - L181002 - L181003 - L189001 - L189002 - L1899 - L1901 - L1902 - L1903 - L1904 - L1905 - L1906 - L1907 - L1908 - L1909 - L1910 - L1911 - L1912 - L1913 - L1914 - L1915 - L1916 - L1917 - L1918 - L1919 - L1920 - L1921 - L1980 - L1999 - L2001 - L2099 - L21 - L22 - L23 - L2401 - L2402 - L2403 - L2499 - L2501 - L2502 - L250301 - L250399 - L2599 - L26 - L80 - L99 - M010101 - M010102 - M010103 - M010199 - M010201 - M01020201 - M01020202 - M010203 - M010299 - M0199 - M0201010101 - M0201010102 - M0201010201 - M0201010202 - M0201020101 - M0201020102 - M0201020201 - M0201020202 - M0201030101 - M0201030102 - M0201030201 - M0201030202 - M020104 - M0201050101 - M0201050102 - M0201050201 - M0201050202 - M020106 - M020107 - M020199 - M0202010101 - M0202010102 - M0202010201 - M0202010202 - M0202020101 - M0202020102 - M0202020201 - M0202020202 - M0202030101 - M0202030102 - M0202030201 - M0202030202 - M020204 - M020205 - M020299 - M020301 - M02030201 - M02030202 - M020399 - M0299 - M030101 - M030102 - M030201 - M03020201 - M03020202 - M03020299 - M030299 - M0303010101 - M0303010103 - M0303010201 - M0303010203 - M03030103 - M03030199 - M03030201 - M03030202 - M03030203 - M03030299 - M0304010101 - M0304010102 - M0304010103 - M0304010201 - M0304010202 - M0304010203 - M0304010301 - M0304010302 - M0304010303 - M03040199 - M030402010101 - M030402010103 - M030402020101 - M030402020103 - M030402030102 - M030402030103 - M03040299 - M030403 - M030404 - M030405 - M030499 - M030501 - M03050201 - M03050202 - M03050299 - M030503 - M030504 - M030505 - M030506 - M030599 - M0399 - M04010101 - M04010102 - M04010199 - M04010201 - M04010202 - M04010203 - M04010299 - M040199 - M040201 - M040202 - M040203 - M040204 - M040299 - M040301 - M040302 - M040303 - M040304 - M040305 - M040306 - M040399 - M04040101 - M04040102 - M04040201 - M04040202 - M04040301 - M04040302 - M040404 - M04040501 - M04040502 - M04040601 - M04040602 - M04040701 - M04040702 - M04040801 - M04040802 - M04040901 - M04040902 - M04041001 - M04041002 - M040411 - M040412 - M040413 - M040414 - M04041501 - M04041502 - M04041503 - M040416 - M040499 - M040501 - M040502 - M040503 - M040504 - M04050501 - M04050502 - M040506 - M040599 - M0406 - M040701 - M040702 - M040703 - M040799 - M0408 - M0409 - M0410 - M0411 - M0412 - M0499 - M050101 - M050102 - M050199 - M050201 - M050202 - M050299 - M0599 - M9001 - M9002 - M9003 - M9099 - N010101 - N0101020101 - N0101020102 - N0101020199 - N01010202 - N01010203 - N01010299 - N010103 - N010180 - N010199 - N010201 - N010202 - N01028001 - N01028002 - N01028003 - N01028099 - N010299 - N010301 - N010302 - N010303 - N01038001 - N01038002 - N01038099 - N010399 - N010401 - N010480 - N010499 - N01800101 - N01800102 - N01800103 - N01800104 - N01800105 - N01800106 - N01800199 - N018099 - N0199 - N02010101 - N02010102 - N02010180 - N02010199 - N020102 - N020180 - N020199 - N020201 - N020202 - N020280 - N020299 - N020301 - N020302 - N020380 - N020399 - N028001 - N02800201 - N02800202 - N02800203 - N02800204 - N02800205 - N02800206 - N02800207 - N02800208 - N02800209 - N02800299 - N028099 - N0299 - N99 - P010101 - P010102 - P010103 - P01010401 - P01010402 - P010199 - P01020101 - P01020180 - P010299 - P0103 - P0180 - P0199 - P02010101 - P02010102 - P02010103 - P02010199 - P02010201 - 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P030102110201 - P030102110202 - P030102110203 - P030102110299 - P030102110301 - P030102110302 - P030102110303 - P030102110399 - P03019001 - P030199 - P0380 - P0399 - P0401 - P0480 - P0499 - P050101 - P050199 - P0502 - P0503 - P050401 - P050499 - P058001 - P058099 - P0599 - P0601010101 - P0601010102 - P0601010199 - P0601010201 - P0601010202 - P0601010299 - P0601020101 - P0601020102 - P0601020199 - P0601020201 - P0601020202 - P0601020299 - P060199 - P060201 - P060299 - P0680 - P0699 - P0701010101 - P0701010102 - P0701010201 - P0701010202 - P07010199 - P070102010101 - P070102010102 - P070102010201 - P070102010202 - P070102020101 - P070102020102 - P070102020201 - P070102020202 - P07010299 - P070180 - P07020101 - P07020102 - P07020199 - P07020201 - P07020202 - P07020203 - P07020204 - P07020299 - P070301010101 - P070301010102 - P070301010103 - P070301010104 - P070301010201 - P070301010202 - P070301010203 - P070301010204 - P0703010201 - P0703010202 - P070301030101 - P070301030102 - P070301030103 - 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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: - Child - ChildIssuingAgency - NumberOfItems - PackagingDi - Status 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 ProductDesignerCountry: type: string description: >- Adress of the Product Desginer Organisation\n\nA geographical address country enum: - AD - AE - AF - AG - AI - AL - AM - AO - AQ - AR - AS - AT - AU - AW - AX - AZ - BA - BB - BD - BE - BF - BG - BH - BI - BJ - BL - BM - BN - BO - BR - BS - BT - BV - BW - BY - BZ - CA - CC - CD - CF - CG - CH - CI - CK - CL - CM - CN - CO - CR - CU - CV - CX - CY - CZ - DE - DJ - DK - DM - DO - DZ - EC - EE - EG - EH - EL - ER - ES - ET - FI - FJ - FK - FM - FO - FR - GA - GD - GE - GF - GG - GH - GI - GL - GM - GN - GP - GQ - GS - GT - GU - GW - GY - HK - HM - HN - HR - HT - HU - ID - IE - IL - IM - IN - IO - IQ - IR - IS - IT - JE - JM - JO - JP - KE - KG - KH - KI - KM - KN - KP - KR - KW - KY - KZ - LA - LB - LC - LI - LK - LR - LS - LT - LU - LV - LY - MA - MC - MD - ME - MF - MG - MH - MK - ML - MM - MN - MO - MP - MQ - MR - MS - MT - MU - MV - MW - MX - MY - MZ - NA - NC - NE - NF - NG - NI - NL - 'NO' - NP - NR - NU - NZ - OM - PA - PE - PF - PG - PH - PK - PL - PM - PN - PR - PS - PT - PW - PY - QA - RE - RO - RS - RU - RW - SA - SB - SC - SD - SE - SG - SH - SI - SJ - SK - SL - SM - SN - SO - SR - SS - ST - SV - SY - SZ - TC - TD - TF - TG - TH - TJ - TK - TL - TM - TN - TO - TR - TT - TV - TW - TZ - UA - UG - UK - UM - US - UY - UZ - VA - VC - VE - VG - VI - VN - VU - WF - WS - XI - YE - YT - ZA - ZM - ZW UnitOfUseDiIssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - GS1 - HIBCC - ICCBBA - IFA 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. ProductDesignerPhone: type: string description: >- For the Product Desginer Organisation Public Contact details need to be provided\n\nThe actor's public contact telephone 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 ProductDesignerCity: type: string description: >- Adress of the Product Desginer Organisation\n\nA geographical address city name 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 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. 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 NewDevice: type: boolean description: >- Defines if the Device can be considered a 'New' Device or not.\n\nA device shall be considered to be ‘new’ if:\n(a) there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter;\n \n(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years.\n DirectMarkingDiIssuingAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of UDIs enum: - GS1 - HIBCC - ICCBBA - IFA 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 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 ProductDesignerMail: type: string description: >- For the Product Desginer Organisation Public Contact details need to be provided\n\nThe actor's public contact email 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 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 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 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 required: - BaseQuantity - CommercialDistributionStatus - Device - DeviceGroup - IssuingAgency - MDN - NewDevice - NumberOfReuses - ProductionIdentifier - ReferenceNumber - ReqSterilizatonPriorUse - Sterile DEVICE_GROUP_EU_UDI_IVDR: type: object properties: 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 OrgUnit: type: string DeviceIntendedProfessionalTesting: type: boolean description: >- Property defines if the Device is designed to be used for Professional Testing or not 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_A - CLASS_B - CLASS_C - CLASS_D KitDevice: type: boolean description: >- Property defines if the Basic UDI-DI is refering to a Kit.\n\nProperty is a applicable for Standard Devices (not Systems or Procedure Packs)\n\nOption Kit is only applicable in case of IVDR Devices 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: - IVDR_PRODUCTION_QUALITY_ASSURANCE - IVDR_QUALITY_MANAGEMENT_SYSTEM - IVDR_TECHNICAL_DOCUMENTATION - IVDR_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: - '0050' - '0123' - '0124' - '0197' - '0344' - '0373' - '0459' - '0483' - '0537' - '2265' - '2797' - '2962' - '3018' 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 DeviceIntendedForSelfTesting: type: boolean description: >- Property defines if the Device is Self Patient testing device or not. \n\n'Device for self-testing' means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services; DeviceContainsMicrobialSubstances: type: boolean description: >- Property defines if the Device contains presence of substances of microbial origin 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: - IVDR_SOFTWARE Reagent: type: boolean description: Property defines if the Device is a reagent or not DeviceGroupAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of Basic UDIs enum: - GS1 - HIBCC - ICCBBA - IFA HumanTissuesCells: type: boolean description: >- Property defines if the Device has presence of human tissues or cells or their derivates DeviceCompanionDiagnostics: type: boolean description: >- Property defines if the Device corresponds to a device that has a role of Companion Diagnostic device or not.\n\n'Companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:\n- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or\n- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product DeviceIntendedForNearPatientTesting: type: boolean description: >- Property defines if the Device device is Near Patient testing or not.\n\n'Device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional; AnimalTissuesCells: type: boolean description: >- Property defines if the Device has presence of animal tissues or cells or their derivates Instrument: type: boolean description: Property defines if the Device is an Instrument or not 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: - IVDR 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 - CH - 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 - 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 - SS - ST - SV - SX - SY - SZ - TC - TD - TF - TG - TH - TJ - TK - TL - TM - TN - TO - TT - TV - TW - TZ - UA - UG - UK - 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 MFActorCode: type: string description: SRN of the Manufacturer that registers the Device required: - AnimalTissuesCells - ApplicableLegislation - DeviceCompanionDiagnostics - DeviceContainsMicrobialSubstances - DeviceGroup - DeviceGroupAgency - DeviceIntendedForNearPatientTesting - DeviceIntendedForSelfTesting - DeviceIntendedProfessionalTesting - HumanTissuesCells - Instrument - KitDevice - MFActorCode - Reagent - RiskClass 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 ````