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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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25.09.2026 00:53

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CL AIA-PACK TRAb CONTROL SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212688
Basic UDI-DI: B-04560189212688
Reference: 0025416
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK TgAb CONJUGATE

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212367
Basic UDI-DI: B-04560189212367
Reference: 0020709
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK TPOAb CONJUGATE

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212350
Basic UDI-DI: B-04560189212350
Reference: 0020708
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK TgAb CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211476
Basic UDI-DI: B-04560189211476
Reference: 0020391
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK TPOAb CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189210912
Basic UDI-DI: B-04560189210912
Reference: 0020490
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK TgAb CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189210868
Basic UDI-DI: B-04560189210868
Reference: 0025491
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

GLUTÉNÉRZÉKENYSÉG GYORSTESZT

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164860800
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88B00KIT01HU
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861494
Basic UDI-DI: 764016486CE2H867
Reference: CE2H8PR00KIT01IT
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PRIMA HOME TEST

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861647
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88000BAG01ED
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

++B261CANATP4160X6

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANATP4160X6
Basic UDI-DI: B-++B261CANATP4160X6
Reference: CAN-ATP-4160
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANATG4150TY

CAN-ATG-4150

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANATG4150TY
Basic UDI-DI: B-++B261CANATG4150TY
Reference: CAN-ATG-4150
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TSHR (eCLIA)

50T，2×50T，100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063850
Basic UDI-DI: 69703416803205088K3
Reference: 0320511301
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroid peroxidase test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406924
Basic UDI-DI: 697029753461LS
Reference: HGCL69
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-thyroglobulin Antibody test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406900
Basic UDI-DI: 697029753462LU
Reference: HGCL70
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgA CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546584
Basic UDI-DI: 697015090000322H9
Reference: CMQ3005
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546485
Basic UDI-DI: 697015090000321H7
Reference: CMQ2905
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-sp100 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545983
Basic UDI-DI: 697015090000318HJ
Reference: CMQ2605
EMDN: W0102100706
EMDN description: SP 100 ANTIBODIES
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-gp210 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545884
Basic UDI-DI: 697015090000317HG
Reference: CMQ2505
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

AMA-M2 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545785
Basic UDI-DI: 697015090000316HE
Reference: CMQ2405
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-GBM IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545686
Basic UDI-DI: 697015090000315HC
Reference: CMQ1705
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details