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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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MyTest Celiachia

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-300077LZ
Basic UDI-DI: B-300077LZ
Reference: 300077
EMDN: W0102100604
EMDN description: GLIADIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 25.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Anti-ovarian Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A036D4
Basic UDI-DI: B-A036D4
Reference: INDICAID™ Anti-ovarian Antibody Test
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid peroxidase antibody (Anti-TPO) Diagnostic Kit（Immunochromatographic Assay）

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765590
Basic UDI-DI: B-06971348765590
Reference: MF-121-25
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid peroxidase antibody (Anti-TPO) Diagnostic Kit（Immunochromatographic Assay）

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762094
Basic UDI-DI: B-06971348762094
Reference: MF-121-20
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® tTG IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200882
Basic UDI-DI: B-08056771200882
Reference: 310320
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

LIAISON® Control TSH-R Ab

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104340
Basic UDI-DI: 80567713118114J
Reference: 311811
EMDN: W0102100399
EMDN description: THYROID-AUTO-IMMUNE DISEASE - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

D-R1331523

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1331523
Basic UDI-DI: B-R1331523
Reference: R13315
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-R13314ZW

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R13314ZW
Basic UDI-DI: B-R13314ZW
Reference: R13314
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-R13313ZU

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R13313ZU
Basic UDI-DI: B-R13313ZU
Reference: R13313
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-R13311ZQ

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R13311ZQ
Basic UDI-DI: B-R13311ZQ
Reference: R13311
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Anti-TG Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TG Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962115
Basic UDI-DI: 0405686901369VV
Reference: 10381655
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

AESKULISA® ssDNA-A

AESKULISA® ssDNA-A s

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500678
Basic UDI-DI: B-04250289500678
Reference: 3145
EMDN: W0102100106
EMDN description: SS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:03

Manufacturer products View details

AESKULISA® ssDNA-Check

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500661
Basic UDI-DI: B-04250289500661
Reference: 3144
EMDN: W0102100106
EMDN description: SS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:03

Manufacturer products View details

AESKULISA® dsDNA-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500654
Basic UDI-DI: B-04250289500654
Reference: 3143
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:03

Manufacturer products View details

AESKULISA® dsDNA-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500647
Basic UDI-DI: B-04250289500647
Reference: 3142
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:03

Manufacturer products View details

Antinuclear Antibody (ANA) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OANA-402D7
Basic UDI-DI: B-OANA-402D7
Reference: OANA-402
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Anti-TPO Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TPO Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962153
Basic UDI-DI: 0405686901370VE
Reference: 10381649
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608570
Basic UDI-DI: 0405686902269VX
Reference: 11206075
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti-Thyroid Peroxidase II (aTPOII)

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608761
Basic UDI-DI: 0405686902269VX
Reference: 11206077
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608747
Basic UDI-DI: 0405686902269VX
Reference: 11206074
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details