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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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24.09.2026 14:57

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25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76487GM
Basic UDI-DI: B-DC76487GM
Reference: DC76487
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-β2-Glycoprotein I IgM

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76449GD
Basic UDI-DI: B-DC76449GD
Reference: DC76449
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Antisperm Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5093
Basic UDI-DI: B-A5093
Reference: INDICAID™ Antisperm Antibody Test
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Diagnostic Screening Test for Sperm Concentration

cassette

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990302PS
Basic UDI-DI: B-693757990302PS
Reference: JZMD cassette
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-thyroid Peroxidase Antibodies(Anti-TPO) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-99B7
Basic UDI-DI: B-6-99B7
Reference: "REF: USIA00000065M, USIA00000066M"
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-thyroglobulin Antibodies (Anti-TG) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-98B5
Basic UDI-DI: B-6-98B5
Reference: "REF: USIA00000063M, USIA00000064M"
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein 1 IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-124FE
Basic UDI-DI: B-6-124FE
Reference: "REF: USIA00000215M, USIA00000216M"
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein 1 IgG Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-123FC
Basic UDI-DI: B-6-123FC
Reference: "REF: USIA00000211M, USIA00000212M"
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein 1 IgA Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-122FA
Basic UDI-DI: B-6-122FA
Reference: "REF: USIA00000209M, USIA00000210M"
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein 1 IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-121F8
Basic UDI-DI: B-6-121F8
Reference: "REF: USIA00000213M, USIA00000214M"
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-120F6
Basic UDI-DI: B-6-120F6
Reference: "REF: USIA00000207M, USIA00000208M"
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-119FM
Basic UDI-DI: B-6-119FM
Reference: "REF: USIA00000203M, USIA00000204M"
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-117FH
Basic UDI-DI: B-6-117FH
Reference: "REF: USIA00000205M, USIA00000206M"
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin IgA Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-118FK
Basic UDI-DI: B-6-118FK
Reference: "REF: USIA00000201M, USIA00000202M"
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Trophoblast cell membrane antibody Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-116FF
Basic UDI-DI: B-6-116FF
Reference: "REF: USIA00000199M, USIA00000200M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Human chorionic gonadotropin Antibody Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-115FD
Basic UDI-DI: B-6-115FD
Reference: "REF: USIA00000197M, USIA00000198M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Zona Pellucida IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-114FB
Basic UDI-DI: B-6-114FB
Reference: "REF: USIA00000195M, USIA00000196M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Zona Pellucida IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-113F9
Basic UDI-DI: B-6-113F9
Reference: "REF: USIA00000193M, USIA00000194M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Endometrium IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-112F7
Basic UDI-DI: B-6-112F7
Reference: "REF: USIA00000189M, USIA00000190M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Endometrium IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-111F5
Basic UDI-DI: B-6-111F5
Reference: "REF: USIA00000191M, USIA00000192M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details