> ## 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 SPP Submit > Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). ## OpenAPI ````yaml post /api/v1/submit/EU_UDI_SPP 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_SPP: post: tags: - Submission summary: EUDAMED SPP 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: '00315616744805' DeviceGroup: 439990265910KB CommercialDistributionStatus: ON_THE_MARKET ProductionIdentifier: - BATCH_NUMBER ReferenceNumber: 37588-474 MDN: - A0101010101 Sterile: false ReqSterilizatonPriorUse: true AdditionalDeviceDescriptions: - AdditionalDeviceDescription: p36 Test Device AdditionalDeviceDescriptionLanguage: EN deviceGroup: DeviceGroupAgency: GS1 DeviceGroup: 439990265910KB ApplicableLegislation: MDR_SPP SPPType: SYSTEM PRActorCode: DE-PR-000018401 DeviceName: p36 Test Device Name RiskClass: CLASS_I MedicalPurposes: - MedicalPurposeLanguage: EN MedicalPurpose: Medicinal Purpose Full Data Example: description: Full Data Example value: device: IssuingAgency: GS1 Device: '00323079270199' Material: 123456-001 MaterialText: p36 Test Device OrgUnit: Bad Hersfeld DeviceGroup: 439990279001K4 CommercialDistributionStatus: ON_THE_MARKET ProductionIdentifier: - MANUFACTURING_DATE - BATCH_NUMBER ReferenceNumber: 37588-474 SecondaryDiAgency: HIBCC SecondaryDi: +A999P36TESTDEVICEXX MDN: - A0101010101 Website: www.p36.io Sterile: false ReqSterilizatonPriorUse: true Packages: - PackagingDi: '00359412962322' NumberOfItems: 10 Child: '00363932443216' ChildIssuingAgency: GS1 Status: ON_THE_MARKET 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: 439990279001K4 ApplicableLegislation: MDR_SPP OrgUnit: Bad Hersfeld SPPType: SYSTEM PRActorCode: DE-PR-000018401 DeviceName: p36 Test Device Name RiskClass: CLASS_I DeviceModel: p36 Test Device Name MedicalPurposes: - MedicalPurposeLanguage: EN MedicalPurpose: Medicinal Purpose 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_SPP' description: required for all EC submissions deviceGroup: $ref: '#/components/schemas/DEVICE_GROUP_EU_UDI_SPP' 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_SPP: type: object properties: OrgUnit: type: string 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 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 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 SecondaryDiAgency: 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 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 - 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K0202010201 - K0202010202 - K0202010301 - K0202010302 - K0202010401 - K0202010402 - K0202010501 - K0202010502 - K0202010601 - K0202010602 - K0202010701 - K0202010702 - K0202010801 - K0202010802 - K0202010901 - K0202010902 - K02020199 - K020280 - K020299 - K02030101 - K02030102 - K02030103 - K02030104 - K02030105 - K02030106 - K02030107 - K02030108 - K02030109 - K02030110 - K02030199 - K020380 - K020399 - K0204010101 - K0204010102 - K0204010201 - K0204010202 - K0204010301 - K0204010302 - K0204010401 - K0204010402 - K0204010501 - K0204010502 - K0204010601 - K0204010602 - K0204010701 - K0204010702 - K0204010801 - K0204010802 - K02040109 - K02040199 - K020480 - K020499 - K02050101 - K02050102 - K02050103 - K02050104 - K02050105 - K02050106 - K02050107 - K02050108 - K02050109 - K02050110 - K0299 - K0301 - K030201 - K030202 - K030203 - K030204 - K030205 - K030206 - K030207 - K030208 - K030209 - K030210 - K030211 - K030212 - K030299 - K0380 - K0399 - L010101 - L010102 - L010103 - L0102 - L0103 - L01040101 - L01040102 - L01040103 - L01040199 - L01040201 - L01040202 - L01040299 - L010403 - L01040401 - L01040402 - L01040501 - L01040502 - L01040503 - L01040504 - L01040505 - L01040506 - L01040507 - L01040508 - L0104050901 - L0104050999 - L01040510 - L01040599 - L01040601 - L01040602 - L01040603 - L01040604 - L01040699 - L01040701 - L01040702 - L01040799 - L0104080101 - L0104080102 - L0104080199 - L01040899 - L010409 - L01041001 - L01041099 - L0104110101 - L0104110102 - L0104110103 - L0104110199 - L0104110201 - L0104110202 - L0104110299 - L01041199 - L01041201 - L01041202 - L01041299 - L010413 - L010499 - L010701 - L010702 - L010703 - L0180 - L0199 - L0201 - L0202 - L0203 - L0204 - L0205 - L0206 - L0207 - L020801 - L020802 - L0299 - L030101 - L030199 - L031101 - L031102 - L031103 - L031104 - L031199 - L031201 - L031202 - L031203 - L031204 - L031205 - L031280 - L031299 - L031301 - L031302 - L031303 - L03130401 - L03130402 - L03130403 - L03130499 - L031305 - L031306 - L031307 - L031308 - 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L060412 - L060413 - L060480 - L060499 - L06050101 - L06050199 - L06050201 - L06050202 - L06050299 - L06060101 - L06060102 - L06060103 - L06060199 - L060602 - L0606030101 - L0606030199 - L06060399 - L060604 - L060699 - L0607 - L0608 - L0609 - L0610 - L0611 - L0612 - L0699 - L070701 - L0707020101 - L0707020199 - L07070202 - L070703 - L070704 - L070705 - L070799 - L0708010101 - L070801018001 - L070801018099 - L0708010199 - L07080102 - L07080103 - L07080104 - L0708010501 - L0708010502 - L0708010503 - L0708010599 - L07080199 - L070802 - L070803 - L070804 - L070805 - L0708060101 - L0708060199 - L07080699 - L070807 - L07080801 - L07080899 - L070809 - L070810 - L070899 - L0801 - L0804 - L080501 - L08050201 - L08050299 - L080599 - L08060101 - L08060199 - L08060201 - L08060299 - L0807 - L080801 - L080802 - L080803 - L080804 - L080805 - L080806 - L080899 - L0809 - L0899 - L0901 - L0902 - L0903 - L090401 - L090402 - L090403 - L090404 - L0908 - L090901 - L090902 - L090903 - L090999 - L091001 - L091002 - L091099 - L091101 - L091102 - L091103 - L091104 - L091105 - L091106 - L091199 - L091201 - L091202 - L091301 - L091302 - L091303 - L091304 - L091305 - L091306 - L091307 - L091399 - L0914 - L0915 - L0916 - L0917 - L0918 - L0919 - L0920 - L0921 - L0922 - L0923 - L0924 - L0925 - L0926 - L0927 - L098001 - L098002 - L098003 - L098099 - L0999 - L1001 - L1003 - L1004 - L1005 - L1099 - L1102 - L1103 - L1104 - L11050101 - L11050199 - L110502 - L11050301 - L11050399 - L110599 - L110601 - L110602 - L11060301 - L11060399 - L110604 - L110699 - L11070101 - L11070199 - L110702 - L110799 - L1108 - L1109 - L1110 - L1111 - L1112 - L1113 - 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 - P02010202 - P02010299 - P020103 - P020180 - P020199 - P020201 - P020202 - P020203 - P020299 - P020301 - P020399 - P0204 - P0205 - P0280 - P0299 - P030101030101 - P030101030102 - P030101030103 - P030101030104 - P030101030199 - P030101030201 - P030101030202 - P030101030203 - P030101030299 - P030101030301 - P030101030302 - P030101030303 - P030101030399 - P030101040101 - 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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 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 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 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: - AdditionalDeviceDescriptions - CommercialDistributionStatus - Device - DeviceGroup - IssuingAgency - MDN - ProductionIdentifier - ReferenceNumber - ReqSterilizatonPriorUse - Sterile DEVICE_GROUP_EU_UDI_SPP: 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 DeviceGroupAgency: type: string description: >- Organization accredited by European Commission to operate a system for the issuance of Basic UDIs enum: - GS1 - HIBCC - ICCBBA - IFA 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 SPPType: type: string description: Determine if it is a System or a Procedure Pack enum: - PROCEDURE_PACK - SYSTEM PRActorCode: type: string description: SRN of the System or Procedure Pack 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 MedicalPurposes: type: object description: >- Description of the Medical Purpose of the System or Procedure Pack.\n\nField is applicable for System and Procedure Packs and refers to the Indication of the specific medical purpose of the System or Procedure Pack Producer maxItems: 0 minItems: 0 properties: MedicalPurpose: type: string description: >- Description of the Medical Purpose of the System or Procedure Pack.\n\nField is applicable for System and Procedure Packs and refers to the Indication of the specific medical purpose of the System or Procedure Pack Producer MedicalPurposeLanguage: 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 required: - MedicalPurpose - MedicalPurposeLanguage 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_SPP 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: - ApplicableLegislation - DeviceGroup - DeviceGroupAgency - MedicalPurposes - PRActorCode - RiskClass - SPPType 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 ````