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22.09.2026 04:45

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63 device results listed.

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Anti-Thyroid Peroxidase (Anti-TPO) Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892985
Basic UDI-DI: B-06974674892985
Reference: 18-02-0170
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:17

Manufacturer products Authorised representative products Authorised representative actors View details

Intact-PTH FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892336
Basic UDI-DI: B-06974674892336
Reference: 18-02-0063
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892183
Basic UDI-DI: B-06974674892183
Reference: 18-02-0048
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO Assay kit CLIA

Anti-TPO Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003441
Basic UDI-DI: B-06974521003441
Reference: SUPM095072
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO Assay kit CLIA

Anti-TPO Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003434
Basic UDI-DI: B-06974521003434
Reference: SUPM095036
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Parathyroid Hormone (PTH) (Time-resolved Fluorescence Immunochromatographic Assay)

Diagnostic Kit for Parathyroid Hormone (PTH) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003311
Basic UDI-DI: B-06974521003311
Reference: SUPF078025
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

TSH, FT3 and FT4 Rapid Test Kit

TSH, FT3 and FT4 Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000028164
UDI-DI: 06974169670081
Basic UDI-DI: B-06974169670081
Reference: A26024008
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

TT4 Rapid Test Kit

A02023002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683795
Basic UDI-DI: B-06973861683795
Reference: A02023002
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316743548
Basic UDI-DI: B-06973316743548
Reference: R331183
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316743531
Basic UDI-DI: B-06973316743531
Reference: R331182
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

25 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316743524
Basic UDI-DI: B-06973316743524
Reference: R331181
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

10 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316743517
Basic UDI-DI: B-06973316743517
Reference: R331180
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Thyroglobulin (Anti-Tg) Assay Reagent Kit (CMIA)

C2KB006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051492
Basic UDI-DI: B-06971792051492
Reference: C2KB006
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

PTH 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: 06970150906399
Basic UDI-DI: 697015090000025GY
Reference: CME0901
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroxine Assay Kit (Chemiluminescent Immunoassay)

Thyroxine Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701342
Basic UDI-DI: B-06955792701342
Reference: S2097E-24
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroxine Assay Kit (Chemiluminescent Immunoassay)

Thyroxine Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701335
Basic UDI-DI: B-06955792701335
Reference: S2097E-48
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI TMA (CLIA)

TMA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145500467
Basic UDI-DI: B-06947145500467
Reference: 130203008M
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI TGA (CLIA)

TGA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145500443
Basic UDI-DI: B-06947145500443
Reference: 130203007M
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

PTH CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222823
Basic UDI-DI: B-06975424222823
Reference: CL30792E
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222816
Basic UDI-DI: B-06975424222816
Reference: CL30752E
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details