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IMMULITE 2000 Rapid TSH

IVDR_67_LLB_DUB-C_B_KIT_Rapid 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: 00630414962030
Basic UDI-DI: 0405686901404V6
Reference: 10381652
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

IMMULITE 2000 TSI

IVDR_67_LLB_DUB-C_B_REAG_KIT_TSI

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414597171
Basic UDI-DI: 0405686901415VB
Reference: 10713448
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Thyroglobulin (Tg)

IVDR_67_LLB_DUB-C_C_KIT_Thyroglobulin

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414238418
Basic UDI-DI: 0405686901464VQ
Reference: 11200450
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® FT4

IVDR_67_TTN_DUB-C_B_REAG_FT4

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414535418
Basic UDI-DI: 0405686900788WE
Reference: 10282218
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine Test Kit (FIA)

VID64

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID6439
Basic UDI-DI: B-VID6439
Reference: VID64-05-011
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine Test Kit (FIA)

VID63

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID6337
Basic UDI-DI: B-VID6337
Reference: VID63-05-011
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroxine Test Kit (FIA)

VID22

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID222R
Basic UDI-DI: B-VID222R
Reference: VID22-05-011
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Triiodothyronine Test Kit (FIA)

VID21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID212P
Basic UDI-DI: B-VID212P
Reference: VID21-05-011
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Stimulating Hormone Test Kit (FIA)

VID20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID202M
Basic UDI-DI: B-VID202M
Reference: VID20-05-011
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:21

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin Antibody Test Kit (FIA)

VID140

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID140ER
Basic UDI-DI: B-VID140ER
Reference: VID140-05-011
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

T4 Total Thyroxine (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TT4706-AEZC
Basic UDI-DI: B-TT4706-AEZC
Reference: TT4706-AE10Y, TT4706-AE10N, TT4706-AE20Y, TT4706-AE20N
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

T3 Total Triiodothyronine (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TT3706-AEYT
Basic UDI-DI: B-TT3706-AEYT
Reference: TT3706-AE10Y, TT3706-AE10N, TT3706-AE20Y, TT3706-AE20N
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Thyroid Stimulating Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TSH706-AEAX
Basic UDI-DI: B-TSH706-AEAX
Reference: TSH706-AE10Y, TSH706-AE10N, TSH706-AE20Y, TSH706-AE20N
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Tg Thyroglobulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TG706-AE8E
Basic UDI-DI: B-TG706-AE8E
Reference: TG706-AE10Y, TG706-AE10N, TG706-AE20Y, TG706-AE20N
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-634D

Free Thyroxine Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-634D
Basic UDI-DI: B-TD-HNKX-CED-634D
Reference: /
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-624B

Free Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-624B
Basic UDI-DI: B-TD-HNKX-CED-624B
Reference: /
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-033T

Total Thyroxine Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-033T
Basic UDI-DI: B-TD-HNKX-CED-033T
Reference: /
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-023R

Total Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-023R
Basic UDI-DI: B-TD-HNKX-CED-023R
Reference: /
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-013P

Thyroid Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-013P
Basic UDI-DI: B-TD-HNKX-CED-013P
Reference: /
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-Q00209YK

N/A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Q00209YK
Basic UDI-DI: B-Q00209YK
Reference: Q00209
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 05:22

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