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EUDAMED Device Search

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FREND Free T4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540382
Basic UDI-DI: B-08809317540382
Reference: FRT4 AP 020
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND Thyroid Duo

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540368
Basic UDI-DI: B-08809317540368
Reference: FRTD 020
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

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FREND Free T4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540191
Basic UDI-DI: B-08809317540191
Reference: FRT4 020
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND TSH

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540016
Basic UDI-DI: B-08809317540016
Reference: FRTS 025
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur TSH3-Ultra

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414535654
Basic UDI-DI: 0405686901633VP
Reference: 10282379
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Thyroid Uptake (TUp)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600246
Basic UDI-DI: 0405686901635VT
Reference: 10995711
EMDN: W01020406
EMDN description: T- UPTAKE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Thyroid Uptake (TUp)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600253
Basic UDI-DI: 0405686901635VT
Reference: 10995712
EMDN: W01020406
EMDN description: T- UPTAKE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Third Generation TSH

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962184
Basic UDI-DI: 0405686901408VE
Reference: 10381667
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM TSH3-Ultra II (TSH3ULII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414624518
Basic UDI-DI: 0405686902233VA
Reference: 11208706
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM TSH3-Ultra II (TSH3ULII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414624525
Basic UDI-DI: 0405686902233VA
Reference: 11208707
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ TSH/T4/T3 (FIA)

VMPO121EP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998271837
Basic UDI-DI: B-08684998271837
Reference: VMPO121
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

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RapidFor™ T4 Rapid Test Kit (FIA)

VMPO03

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039328
Basic UDI-DI: B-08684595039328
Reference: VMPO03FC
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ T3 Rapid Test Kit (FIA)

VMPO02

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039311
Basic UDI-DI: B-08684595039311
Reference: VMPO02FC
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™FT4 Rapid Test Kit (FIA)

VMPO14

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250223
Basic UDI-DI: B-08683548250223
Reference: VMPO14
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

RapidFor™ FT3 Rapid Test Kit (FIA)

VMPO13

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250216
Basic UDI-DI: B-08683548250216
Reference: VMPO13
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

RapidFor™ T4 Rapid Test Kit (FIA)

VMPO03

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250148
Basic UDI-DI: B-08683548250148
Reference: VMPO03
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:07

Manufacturer products View details

RapidFor™T3 Rapid Test Kit (FIA)

VMPO02

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250131
Basic UDI-DI: B-08683548250131
Reference: VMPO02
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:07

Manufacturer products View details

T4 CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541282
Basic UDI-DI: 697015090000002GL
Reference: CME0205
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

TSH CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541381
Basic UDI-DI: 697015090000003GN
Reference: CME0305
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

T3 CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541480
Basic UDI-DI: 697015090000001GJ
Reference: CME0105
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details