curl --request POST \
--url https://api-preview.udiconnect.io/api/v1/submit/EU_UDI_IVDR \
--header 'Authorization: <api-key>' \
--header 'Content-Type: application/json' \
--data '
{
"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
}
}
'{
"agency": "EC",
"requestId": "string",
"modelInformation": "string",
"status": "SUCCESS",
"statusText": "Submission successfully validated and accepted"
}API Documentation
EUDAMED IVDR Submit
Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System).
POST
/
api
/
v1
/
submit
/
EU_UDI_IVDR
curl --request POST \
--url https://api-preview.udiconnect.io/api/v1/submit/EU_UDI_IVDR \
--header 'Authorization: <api-key>' \
--header 'Content-Type: application/json' \
--data '
{
"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
}
}
'{
"agency": "EC",
"requestId": "string",
"modelInformation": "string",
"status": "SUCCESS",
"statusText": "Submission successfully validated and accepted"
}Authorizations
Body
application/json
Data to be submitted
Response
Submission Successful
Response for successful submission processing
Regulatory agency information
Available options:
COMMON_DEVICE_DATA, FDA, EC, NMPA, MFDS, GDSN, SFDA, TFDA, TGA, HSA The unique identifier for the submission request
Information about the model and use case data used for processing the request
Submission response status
Available options:
INTERNAL_ERROR, SUCCESS, BLOCKED, VALIDATION_FAILED, INVALID_REQUEST Submission response status text