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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

Authorization
string
header
required

Body

application/json

Data to be submitted

actorCode
string
securityToken
string
authorizedRepresentativeCode
string
device
object

required for all EC submissions

deviceGroup
object

required for all EC submissions if not already submitted & published

Response

Submission Successful

Response for successful submission processing

agency
enum<string>

Regulatory agency information

Available options:
COMMON_DEVICE_DATA,
FDA,
EC,
NMPA,
MFDS,
GDSN,
SFDA,
TFDA,
TGA,
HSA
requestId
string

The unique identifier for the submission request

modelInformation
string

Information about the model and use case data used for processing the request

status
enum<string>

Submission response status

Available options:
INTERNAL_ERROR,
SUCCESS,
BLOCKED,
VALIDATION_FAILED,
INVALID_REQUEST
statusText
string

Submission response status text