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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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02.08.2026 12:03

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276 device results listed.

Page 12 / 14

MAGICL Anti-TSHR (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798562
Basic UDI-DI: B-06954414798562
Reference: /
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Tg (CLIA)

MAGICL Tg (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798555
Basic UDI-DI: B-06954414798555
Reference: /
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Anti-TPO (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798098
Basic UDI-DI: B-06954414798098
Reference: /
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Anti-Tg (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798081
Basic UDI-DI: B-06954414798081
Reference: /
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Tg Fast Test Kit (Immunofluorescence Assay)

Anti-Tg Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792218
Basic UDI-DI: B-06954414792218
Reference: /
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO Fast Test Kit (Immunofluorescence Assay)

Anti-TPO Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792201
Basic UDI-DI: B-06954414792201
Reference: /
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405056 IM4401056 IM4406056 IM4404056

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403272
Basic UDI-DI: 69506174IM440056DF
Reference: IM4404056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405056 IM4401056 IM4406056 IM4404056

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403265
Basic UDI-DI: 69506174IM440056DF
Reference: IM4406056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405056 IM4401056 IM4406056 IM4404056

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403258
Basic UDI-DI: 69506174IM440056DF
Reference: IM4401056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405056 IM4401056 IM4406056 IM4404056

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403241
Basic UDI-DI: 69506174IM440056DF
Reference: IM4405056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405057 IM4401057 IM4406057 IM4404057

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403234
Basic UDI-DI: 69506174IM440057DH
Reference: IM4404057
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405057 IM4401057 IM4406057 IM4404057

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403227
Basic UDI-DI: 69506174IM440057DH
Reference: IM4406057
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405057 IM4401057 IM4406057 IM4404057

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403210
Basic UDI-DI: 69506174IM440057DH
Reference: IM4401057
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

IM4405057 IM4401057 IM4406057 IM4404057

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403203
Basic UDI-DI: 69506174IM440057DH
Reference: IM4405057
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TG 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: 06942359506373
Basic UDI-DI: 697015090000022GS
Reference: CME0610
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TG 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: 06942359506359
Basic UDI-DI: 697015090000022GS
Reference: CME0608
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-thyroid Peroxidase Antibody CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590087
Basic UDI-DI: 697518250F116072L
Reference: F11607
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-thyroglobulin Antibody CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590070
Basic UDI-DI: 697518250F116062J
Reference: F11606
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ ANTI-TPO

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404885
Basic UDI-DI: 697139043030983
Reference: 010309601
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ ANTI-TG

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404861
Basic UDI-DI: 69713904303087Z
Reference: 010308601
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details