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+ENTIFT4105007

NovaLisa® Free T4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFT4105007
Basic UDI-DI: B-+ENTIFT4105007
Reference: FT41050
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIDNOV0540A

Total T4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV0540A
Basic UDI-DI: B-+ENTIDNOV0540A
Reference: DNOV054
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDNOV05107

Free T3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV05107
Basic UDI-DI: B-+ENTIDNOV05107
Reference: DNOV051
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDNOV05309

Total T3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV05309
Basic UDI-DI: B-+ENTIDNOV05309
Reference: DNOV053
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

08800111723421

i-fT3-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723421
Basic UDI-DI: 88001117IPBA01IA20VV
Reference: 16FT310D
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111723339

i-T4-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723339
Basic UDI-DI: 88001117IPBA01IA22VZ
Reference: 16T410D
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Free Thyroxine (FT4)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599137
Basic UDI-DI: 0405686900788WE
Reference: 10995589
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur TSH3-Ultra II (TSH3ULII)

IVDR_67_TTN_DUB-C_B_REAG_KIT_TSH3ULII

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414624488
Basic UDI-DI: 0405686902233VA
Reference: 11208702
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® T3

IVDR_67_TTN_DUB-C_B_KIT_T3

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414554617
Basic UDI-DI: 0405686901627VU
Reference: 10285732
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur TSH3-Ultra

IVDR_67_TTN_DUB-C_B_KIT_TSH3-UL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414535647
Basic UDI-DI: 0405686901633VP
Reference: 10282378
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Tg Master Curve Material (Tg MCM)

IVDR_67_LLB_DUB-C_C_REAG_Tg MCM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414238401
Basic UDI-DI: 0405686902142V6
Reference: 11200449
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® FT3

IVDR_67_TTN_DUB-C_B_REAG_FT3

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414207520
Basic UDI-DI: 0405686901713VN
Reference: 10310317
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® Tup

IVDR_67_TTN_DUB-C_B_KIT_TUp

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177120
Basic UDI-DI: 0405686901635VT
Reference: 10309966
EMDN: W01020406
EMDN description: T- UPTAKE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® T4

IVDR_67_TTN_DUB-C_B_KIT_T4

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177045
Basic UDI-DI: 0405686901628VW
Reference: 10309960
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® TSH

IVDR_67_TTN_DUB-C_B_KIT_TSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177038
Basic UDI-DI: 0405686901632VM
Reference: 10309959
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_Thyroid Stimulating Hormone

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022081
Basic UDI-DI: 0405686901199VU
Reference: 10464524
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Total T4

IVDR_67_LLB_DUB-C_B_REAG_KIT_Total T4

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966038
Basic UDI-DI: 0405686901413V7
Reference: 10381664
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Total T3

IVDR_67_LLB_DUB-C_B_REAG_KIT_Total T3

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966021
Basic UDI-DI: 0405686901412V5
Reference: 10381657
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Thyroid Uptake

IVDR_67_LLB_DUB-C_B_KIT_Thyroid Uptake

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962207
Basic UDI-DI: 0405686901409VG
Reference: 10381669
EMDN: W01020406
EMDN description: T- UPTAKE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Third Generation TSH

IVDR_67_LLB_DUB-C_B_KIT_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: 00630414962160
Basic UDI-DI: 0405686901408VE
Reference: 10381665
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details