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Ask AI
curl --request POST \
--url https://api.udiconnect.io/api/v1/validate/EU_UDI_MDR \
--header 'Authorization: <api-key>' \
--header 'Content-Type: application/json' \
--data '
"{\n \"device\": {\n \"IssuingAgency\": \"GS1\",\n \"Device\": \"00308676965723\",\n \"DeviceGroup\": \"439990237188JM\",\n \"Material\": \"37588-474\",\n \"BaseQuantity\": 1,\n \"CommercialDistributionStatus\": \"ON_THE_MARKET\",\n \"ProductionIdentifier\": [\n \"BATCH_NUMBER\"\n ],\n \"ReferenceNumber\": \"37588-474\",\n \"MDN\": [\n \"A0101010201\"\n ],\n \"NumberOfReuses\": 0,\n \"ContainsLatex\": false,\n \"Reprocessed\": false,\n \"Sterile\": false,\n \"ReqSterilizatonPriorUse\": true,\n \"MarketInfos\": [\n {\n \"Country\": \"DE\",\n \"OriginalPlacedOnTheMarket\": true\n }\n ],\n \"AdditionalTradeNames\": [\n {\n \"AdditionalTradeName\": \"Trade Name\",\n \"AdditionalTradeNameLanguage\": \"EN\"\n }\n ]\n },\n \"deviceGroup\": {\n \"DeviceGroupAgency\": \"GS1\",\n \"DeviceGroup\": \"439990237188JM\",\n \"ApplicableLegislation\": \"MDR\",\n \"MFActorCode\": \"DE-MF-000001723\",\n \"DeviceName\": \"Device Name\",\n \"RiskClass\": \"CLASS_I\",\n \"AnimalTissuesCells\": false,\n \"HumanTissuesCells\": false,\n \"DeviceImplantable\": false,\n \"DeviceHasMeasuringFunction\": false,\n \"DeviceReusableSurgicalInstrument\": false,\n \"ActiveDevice\": false,\n \"DeviceIntendedToAdministerMedicine\": false,\n \"SystemDevice\": false,\n \"ProcedurePackDevice\": false,\n \"HumanProductCheck\": false,\n \"MedicinalProductCheck\": false\n }\n}\n"
'Copy
Ask AI
"{\n \"status\": \"successful\",\n \"message\": \"Validation successful\"\n}"API Documentation
Validate UDI submission data
Validates UDI device data against the specified data model schema and business rules. This endpoint performs comprehensive validation including schema validation, business rule checks, and data integrity verification without actually submitting the data to regulatory agencies.
POST
/
api
/
v1
/
validate
/
EU_UDI_MDR
Copy
Ask AI
curl --request POST \
--url https://api.udiconnect.io/api/v1/validate/EU_UDI_MDR \
--header 'Authorization: <api-key>' \
--header 'Content-Type: application/json' \
--data '
"{\n \"device\": {\n \"IssuingAgency\": \"GS1\",\n \"Device\": \"00308676965723\",\n \"DeviceGroup\": \"439990237188JM\",\n \"Material\": \"37588-474\",\n \"BaseQuantity\": 1,\n \"CommercialDistributionStatus\": \"ON_THE_MARKET\",\n \"ProductionIdentifier\": [\n \"BATCH_NUMBER\"\n ],\n \"ReferenceNumber\": \"37588-474\",\n \"MDN\": [\n \"A0101010201\"\n ],\n \"NumberOfReuses\": 0,\n \"ContainsLatex\": false,\n \"Reprocessed\": false,\n \"Sterile\": false,\n \"ReqSterilizatonPriorUse\": true,\n \"MarketInfos\": [\n {\n \"Country\": \"DE\",\n \"OriginalPlacedOnTheMarket\": true\n }\n ],\n \"AdditionalTradeNames\": [\n {\n \"AdditionalTradeName\": \"Trade Name\",\n \"AdditionalTradeNameLanguage\": \"EN\"\n }\n ]\n },\n \"deviceGroup\": {\n \"DeviceGroupAgency\": \"GS1\",\n \"DeviceGroup\": \"439990237188JM\",\n \"ApplicableLegislation\": \"MDR\",\n \"MFActorCode\": \"DE-MF-000001723\",\n \"DeviceName\": \"Device Name\",\n \"RiskClass\": \"CLASS_I\",\n \"AnimalTissuesCells\": false,\n \"HumanTissuesCells\": false,\n \"DeviceImplantable\": false,\n \"DeviceHasMeasuringFunction\": false,\n \"DeviceReusableSurgicalInstrument\": false,\n \"ActiveDevice\": false,\n \"DeviceIntendedToAdministerMedicine\": false,\n \"SystemDevice\": false,\n \"ProcedurePackDevice\": false,\n \"HumanProductCheck\": false,\n \"MedicinalProductCheck\": false\n }\n}\n"
'Copy
Ask AI
"{\n \"status\": \"successful\",\n \"message\": \"Validation successful\"\n}"Authorizations
Body
application/json
Data to be validated
required for all EC
Show child attributes
Show child attributes
Reference to the Basic UDI-DI to which the Device is associated
The Device Nomenclature Code(s) associated with the UDI-DI. \nThe corresponding EMDN Nomenclature Code will be stored in the field\n\n
Available options:
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, J020302, J020380, J020399, J020401, J020402, J020403, J020480, J020499, J0206, J020701, J020780, J020782, J020785, J020792, J020801, J020802, J020803, J020804, J0209, J0210, J0211, J0280, J0299, J0301, J0302, J0303, J0380, J0399, J0401, J0402, J040301, J040380, J040382, J040385, J040392, J0480, J0499, J0501, J0502, J0580, J0601, J0602, J0680, J0701, J0702, J0780, J0799, J99, K01010101, K01010102, K01010103, K01010104, K01010105, K01010180, K01010199, K010102, K01020101, K01020102, K01020103, K01020104, K01020105, K01020106, K01020107, K01020109, K01020110, K01020111, K01020112, K01020113, K01020114, K01020115, K01020116, K01020117, K01020118, K01020119, K01020120, K01020199, K01020201, K01020202, K01020203, K01020204, K01020205, K01020299, K010301, K010302, K010399, K0104, K0105, K0106, K0107, K0108, K0180, K0199, K0201010101, K0201010102, K0201010201, K0201010202, K0201010301, K0201010302, K0201010401, K0201010402, K0201010501, K0201010502, K0201010601, K0201010602, K02010107, K0201010801, K0201010802, K0201010901, K0201010902, K0201011001, K0201011002, K0201011101, K0201011102, K0201011201, K0201011202, K02010113, K02010199, K02010201, K02010202, K02010203, K02010301, K02010302, K02010303, K020180, K020199, K0202010101, K0202010102, 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, L031309, L031310, L031312, 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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 Reference to the Types of UDI-PI (production Identifiers) applicable for the current Device (UDI-DI). Defines the way the production is controled
Available options:
BATCH_NUMBER, EXPIRATION_DATE, MANUFACTURING_DATE, SERIALISATION_NUMBER, SOFTWARE_VERSION Property defines if the Device is a Reprocessesed single use device or not
Property defines if the UDI-DI needs to be sterilised before use or not
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
Property stores the Reference or Catalogue Number of the Device
Property defines if the UDI-DI is labeled as Sterile or not
The base quantity in which the Device is provided
Required range:
x >= 0Property 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
Available options:
MDR Property defines if the Device contains latex into it`s composition
Reference to the list of Countries were the device has been made available
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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
Available options:
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 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)
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
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
Indicates that a product is excluded from submission to the regulatory authority.
Organization accredited by European Commission to operate a system for the issuance of UDIs
Available options:
GS1, HIBCC, ICCBBA, IFA Material number of the device.
Status of the Device (On the EU market, Not intended to be placed on the EU Market, No longer placed on the EU market).
Available options:
NOT_INTENDED_FOR_EU_MARKET, NO_LONGER_PLACED_ON_THE_MARKET, ON_THE_MARKET 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
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Available options:
MDR_PRODUCT_VERIFICATION, MDR_QUALITY_ASSURANCE, MDR_QUALITY_MANAGEMENT_SYSTEM, MDR_TECHNICAL_DOCUMENTATION, MDR_TYPE_EXAMINATION Available options:
0044, 0050, 0051, 0068, 0123, 0124, 0197, 0297, 0318, 0333, 0344, 0373, 0425, 0426, 0459, 0476, 0477, 0482, 0483, 0494, 0537, 0546, 0598, 0633, 1011, 1023, 1282, 1304, 1370, 1383, 1434, 1639, 1912, 1936, 1984, 2265, 2274, 2292, 2409, 2443, 2460, 2696, 2764, 2797, 2803, 2862, 2962, 2975, 3022, 3033 Available options:
0, MDR_MADE_TO_ORDER, MDR_ORTHOPEDIC, MDR_READY_MADE_SPECTACLES, MDR_RIGID_GAS_PERMEABLE, MDR_SOFTWARE, MDR_SPECTACLES_FRAMES, MDR_SPECTACLES_LENSES, MDR_STANDARD_SOFT_CONTACT_LENSES References to the Substances associated to the device
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Field stores the details regarding the type of substance registered (Substance which can be considered a Medicinal Product, Substance which may be considered a medicinal product derived from human blood or plasma or CMR Substance)
Available options:
CRM_ENDOCRINE, HUMAN_PRODUCT_SUBSTANCE, MEDICINAL_PRODUCT_SUBSTANCE When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances\n\nField stores the Name of Substance (applicable for all types of substances - CMR, Endocrine , Medicinal product, Medicinal product derived from human blood or human). \n\nIn case of CMR Substances or Medicinal product and Medicinal product derived from human blood or human plasma , if the #CAS or #EC or INN is provided, field is no longer required
Field stores the INN value for the substance provided.\n\nINN can be provided only for substances which, if used separately, may be considered to be a medicinal product or substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma
Field stores the Type of CMR Substance. It is only applicable when the Substance registered is a CMR Substance
Available options:
CMR_1A, CMR_1B, ENDOCRINE_DISRUPTING Field stores the CAS Code (CAS#) associated to the CMR substance.\n\nCAS# can be provided only for CMR or Endocrine-disrupting substances
Field Stores the EC Code (EC#)associated to the CMR or Endocrine disrupting substance.\n\nEC# can be provided only for CMR or Endocrine-disrupting substances
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).
Reference to the Container Package Structure associated to the UDI-DI
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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)
Available options:
NO_LONGER_PLACED_ON_THE_MARKET, ON_THE_MARKET Unique identifier of the Package UDI-DI
Number of Items in the Package Structure. \n\nUsed when describing the Container Packaging Structure of a Device
Required range:
x >= 0Container 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)
Organization accredited by European Commission to operate a system for the issuance of UDIs
Available options:
GS1, HIBCC, ICCBBA, IFA References to the list of Clinical Sizes associated to the UDI-DI
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Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nClinical Size Precision - mentions how the recording of Data will be performed (as Value, Range or Text is selected)
Available options:
Range, Text, Value Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nThe Type of Clinical Size (example : length, width, etc.)
Available options:
CST1, CST10, CST11, CST12, CST13, CST14, CST15, CST16, CST17, CST18, CST19, CST2, CST20, CST21, CST22, CST23, CST24, CST25, CST26, CST27, CST28, CST29, CST3, CST30, CST31, CST32, CST33, CST34, CST35, CST36, CST37, CST38, CST39, CST4, CST40, CST41, CST42, CST43, CST44, CST45, CST46, CST47, CST48, CST49, CST5, CST50, CST51, CST52, CST53, CST54, CST55, CST56, CST57, CST58, CST59, CST6, CST60, CST61, CST62, CST63, CST65, CST66, CST67, CST7, CST8, CST9 Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nValue that the Clinical Size can get (when Text is selected as Precision)
Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion (either Range, single value or Text), Value and Measuring Unit\n\nValue (Minimum) that the Clinical Size can get (when Value or Range is selected as precision)
Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nMaximum Value that the Clinical Size can get (when Range is selected as precision)
Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit\n\nClinical Size Measure Unit
Available options:
MU01, MU02, MU03, MU04, MU05, MU06, MU07, MU08, MU09, MU10, MU100, MU101, MU102, MU103, MU104, MU105, MU106, MU107, MU108, MU109, MU11, MU110, MU111, MU112, MU113, MU114, MU115, MU116, MU117, MU118, MU119, MU12, MU120, MU121, MU122, MU123, MU124, MU125, MU126, MU127, MU128, MU129, MU13, MU130, MU131, MU132, MU133, MU134, MU135, MU136, MU137, MU138, MU139, MU14, MU140, MU141, MU142, MU143, MU144, MU145, MU146, MU147, MU148, MU149, MU15, MU150, MU151, MU152, MU153, MU154, MU156, MU157, MU158, MU159, MU16, MU160, MU161, MU162, MU163, MU164, MU165, MU166, MU167, MU168, MU169, MU17, MU170, MU172, MU173, MU175, MU176, MU18, MU19, MU20, MU21, MU22, MU23, MU24, MU25, MU26, MU27, MU28, MU29, MU30, MU31, MU32, MU33, MU34, MU35, MU36, MU37, MU38, MU39, MU40, MU41, MU42, MU43, MU44, MU45, MU46, MU47, MU48, MU49, MU50, MU51, MU52, MU53, MU54, MU55, MU56, MU57, MU58, MU59, MU60, MU61, MU62, MU63, MU64, MU65, MU66, MU67, MU68, MU69, MU70, MU71, MU72, MU73, MU74, MU75, MU76, MU77, MU78, MU79, MU80, MU81, MU82, MU83, MU84, MU85, MU86, MU87, MU88, MU89, MU90, MU91, MU92, MU93, MU94, MU95, MU96, MU97, MU98, MU99 Name of the Material of the device.
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
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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 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
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
Organization accredited by European Commission to operate a system for the issuance of UDIs
Available options:
0, GS1, HIBCC, ICCBBA, IFA Organization accredited by European Commission to operate a system for the issuance of Basic UDIs
Available options:
GS1, HIBCC, ICCBBA, IFA References the Storage and Handling Conditions associated to the Device (UDI-DI)
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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.
Available options:
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 Comments or description associated to the values selected form the Storage or handling Conditions or Critical warnings
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
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)
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For the Product Designer Organisation Public Contact details need to be provided
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
Manufacturer`s website where additional information about the device (UDI-DI) are available
Organization accredited by European Commission to operate a system for the issuance of UDIs
Available options:
0, GS1, HIBCC, ICCBBA, IFA Organization accredited by European Commission to operate a system for the issuance of UDIs
Available options:
0, GS1, HIBCC, ICCBBA, IFA Available options:
CLASS_I, CLASS_IIA, CLASS_IIB, CLASS_III Name of the Organisation
Adress of the Product Desginer Organisation
Field stores the reference to the Intended purpose other than medical of the Device (UDI-DI).\n\nField stores the values regarding the Intended purpose of the Device other the medical one`s as they are descubed in the Annex XVI of MDR Regulation
Available options:
BRAIN_ELECTROSTIMULATION, CONTACT_LENSES, EMR, EQUIPMENT_FOR_ADDIPOSE_TISSUE, FILLING_BY_INJECTION, PRODUCT_IN_BODY References the Critical warnings associated to the Device (UDI-DI)
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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
Available options:
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 Comments or description associated to the values selected for the Critical warnings
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AD, AE, AF, AG, AI, AL, AM, AO, AQ, AR, AS, AU, AW, AX, AZ, BA, BB, BD, BF, BH, BI, BJ, BL, BM, BN, BO, BQ, BR, BS, BT, BV, BW, BY, BZ, CA, CC, CD, CF, CG, CI, CK, CL, CM, CN, CO, CR, CU, CV, CW, CX, DJ, DM, DO, DZ, EC, EG, EH, ER, ET, FJ, FK, FM, FO, GA, GB, GD, GE, GF, GG, GH, GI, GL, GM, GN, GP, GQ, GS, GT, GU, GW, GY, HK, HM, HN, HT, ID, IL, IM, IN, IO, IQ, IR, JE, JM, JO, JP, KE, KG, KH, KI, KM, KN, KP, KR, KW, KY, KZ, LA, LB, LC, LK, LR, LS, LY, MA, MC, MD, ME, MF, MG, MH, MK, ML, MM, MN, MO, MP, MQ, MR, MS, MU, MV, MW, MX, MY, MZ, NA, NC, NE, NF, NG, NI, NP, NR, NU, NZ, OM, PA, PE, PF, PG, PH, PK, PM, PN, PR, PS, PW, PY, QA, RE, RS, RU, RW, SA, SB, SC, SD, SG, SH, SJ, SL, SM, SN, SO, SR, ST, SV, SX, SY, SZ, TC, TD, TF, TG, TH, TJ, TK, TL, TM, TN, TO, TT, TV, TW, TZ, UA, UG, UM, US, UY, UZ, VA, VC, VE, VG, VI, VN, VU, WF, WS, YE, YT, ZA, ZM, ZW required for all EC
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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
Property defines if the Basic UDI-DI corresponds to an Active device or not.\n\n'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. \n\nDevices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device
Property defines if the Device is a Reusable Surgical Instrument or not.\n\n'Reusable surgical instrument' means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the Manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. \n\nIn case of Devices being marked as Implantable (field "Implantable" has value "True" )field Reusable Surgical Instruments has by default value "False"
Property defines if the Device has presence of human tissues or cells or their derivates
Property defines if the Basic UDI-DI is refering to a Procedure pack which is a Device in itself (in accordance with the Art. 22(4) MDR ).\n\nProperty is a applicable for Standard Devices (not Systems or Procedure Packs)\n\nOption Procedure pack which is a Device in itself is applicable only in case of MDR Devices
Property defines if the Device has a Measuring Function or not
Property defines if the Basic UDI-DI is refering to a System which is a Device in itself.\n\nProperty is a applicable for Standard Devices (not Systems or Procedure Packs)\n\nOption System which is a Device in itself is applicable only in case of MDR Devices
SRN of the Manufacturer that registers the Device
Defines if the Device containes substances which may be considered medicinal product
Defines if the Device containes substances which may be considered medicinal product derived from human blood or plasma
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
Available options:
CLASS_I, CLASS_IIA, CLASS_IIB, CLASS_III Organization accredited by European Commission to operate a system for the issuance of Basic UDIs
Available options:
GS1, HIBCC, ICCBBA, IFA Property defines if the Device is intended to administer or remove medicinal product
Property defines if the Device has presence of animal tissues or cells or their derivates
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
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MDR Property defines if the Basic UDI-DI corresponds to a device that is Implantable or not.\n\nAny device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.\n\nIn case of Devices having the Risck Class " Class I " field Implantable has by default value "False"
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)
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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
Available options:
MDR_PRODUCT_VERIFICATION, MDR_QUALITY_ASSURANCE, MDR_QUALITY_MANAGEMENT_SYSTEM, MDR_TECHNICAL_DOCUMENTATION, MDR_TYPE_EXAMINATION 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
Available options:
0044, 0050, 0051, 0068, 0123, 0124, 0197, 0297, 0318, 0333, 0344, 0373, 0425, 0426, 0459, 0476, 0477, 0482, 0483, 0494, 0537, 0546, 0598, 0633, 1011, 1023, 1282, 1304, 1370, 1383, 1434, 1639, 1912, 1936, 1984, 2265, 2274, 2292, 2409, 2443, 2460, 2696, 2764, 2797, 2803, 2862, 2962, 2975, 3022, 3033 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
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
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
Available options:
0, MDR_MADE_TO_ORDER, MDR_ORTHOPEDIC, MDR_READY_MADE_SPECTACLES, MDR_RIGID_GAS_PERMEABLE, MDR_SOFTWARE, MDR_SPECTACLES_FRAMES, MDR_SPECTACLES_LENSES, MDR_STANDARD_SOFT_CONTACT_LENSES 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
Property defines if the registered Device is 'sutures', 'staples', 'dental fillings', 'dental braces', 'tooth crowns', 'screws', 'wedges', 'plates wires', 'pins', 'clips and connectors' (these defines are exempted from the regulation imposed to implantable devices).\n\nProperty is applicable only for Devices having Risk Class II b and having the property 'Implantable' marked
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
References the Clinical Investigation Link, storing the details of Clinical Investigations associated to the Basic UDI-DI
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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
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
Available options:
AD, AE, AF, AG, AI, AL, AM, AO, AQ, AR, AS, AU, AW, AX, AZ, BA, BB, BD, BF, BH, BI, BJ, BL, BM, BN, BO, BQ, BR, BS, BT, BV, BW, BY, BZ, CA, CC, CD, CF, CG, CI, CK, CL, CM, CN, CO, CR, CU, CV, CW, CX, DJ, DM, DO, DZ, EC, EG, EH, ER, ET, FJ, FK, FM, FO, GA, GB, GD, GE, GF, GG, GH, GI, GL, GM, GN, GP, GQ, GS, GT, GU, GW, GY, HK, HM, HN, HT, ID, IL, IM, IN, IO, IQ, IR, JE, JM, JO, JP, KE, KG, KH, KI, KM, KN, KP, KR, KW, KY, KZ, LA, LB, LC, LK, LR, LS, LY, MA, MC, MD, ME, MF, MG, MH, MK, ML, MM, MN, MO, MP, MQ, MR, MS, MU, MV, MW, MX, MY, MZ, NA, NC, NE, NF, NG, NI, NP, NR, NU, NZ, OM, PA, PE, PF, PG, PH, PK, PM, PN, PR, PS, PW, PY, QA, RE, RS, RU, RW, SA, SB, SC, SD, SG, SH, SJ, SL, SM, SN, SO, SR, ST, SV, SX, SY, SZ, TC, TD, TF, TG, TH, TJ, TK, TL, TM, TN, TO, TT, TV, TW, TZ, UA, UG, UM, US, UY, UZ, VA, VC, VE, VG, VI, VN, VU, WF, WS, YE, YT, ZA, ZM, ZW 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
Response
OK
Overall status of the validation
Validation message
⌘I