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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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TT4 Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763220049
Basic UDI-DI: B-06971763220049
Reference: 0004-03
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

TT3 Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763220032
Basic UDI-DI: B-06971763220032
Reference: 0003-03
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go TSH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936365
Basic UDI-DI: B-06971225936365
Reference: FIA21025
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go T4 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936297
Basic UDI-DI: B-06971225936297
Reference: FIA23025
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go T3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936280
Basic UDI-DI: B-06971225936280
Reference: FIA22025
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo TSH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935597
Basic UDI-DI: B-06971225935597
Reference: KM13060
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo T4 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935535
Basic UDI-DI: B-06971225935535
Reference: KM18060
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo T3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935474
Basic UDI-DI: B-06971225935474
Reference: KM17060
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo FT4 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935405
Basic UDI-DI: B-06971225935405
Reference: KM16060
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo FT3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935351
Basic UDI-DI: B-06971225935351
Reference: KM15060
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go Free T3 Kit

FIA Go Free T3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931223
Basic UDI-DI: B-06971225931223
Reference: FIA28025
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go Free T4 Kit

FIA Go Free T4 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931216
Basic UDI-DI: B-06971225931216
Reference: FIA29025
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

NEONATAL TSH Screening ELISA

E-GP-576

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471778
Basic UDI-DI: B-05430002471778
Reference: E-GP-576
EMDN: W01020403
EMDN description: NEONATAL THYROID STIMULATING HORMONE
First on market country: Belgium
Authorised representative: -
Last updated: 06.07.2026 08:36

Manufacturer products View details

Free T3 kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100484
Basic UDI-DI: B-04251557100484
Reference: 24-09 A
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details

Free T3 kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100477
Basic UDI-DI: B-04251557100477
Reference: 24-09
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details

Triiodothyronine kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100385
Basic UDI-DI: B-04251557100385
Reference: 24-04 A
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details

Triiodothyronine kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100378
Basic UDI-DI: B-04251557100378
Reference: 24-04
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details

TSH (third generation) kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100347
Basic UDI-DI: B-04251557100347
Reference: 24-02
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:44

Manufacturer products View details

Free Triiodothyronine (CLIA)

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047836
Basic UDI-DI: 69449040AB740000258
Reference: 105-004235-00
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine (CLIA)

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047843
Basic UDI-DI: 69449040004H-FT4*******QZ
Reference: 105-004236-00
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details