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323 device results listed.

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ElisaRSR™TRAb Fast™

IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600109
Basic UDI-DI: B-05056509600109
Reference: FTE/96
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

ElisaRSR™TRAb 3rd Generation

IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600093
Basic UDI-DI: B-05056509600093
Reference: TRE/96/3A
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

ElisaRSR™TRAb 2nd Generation

IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600086
Basic UDI-DI: B-05056509600086
Reference: TRE/96/2A
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

abia TSH

IVD generalNot specifiedOn the marketSingle use

Manufacturer: AB Diagnostic Systems GmbH
Manufacturer SRN: DE-MF-000025407
UDI-DI: 04262351590036
Basic UDI-DI: B-04262351590036
Reference: DK.006.01.3
EMDN: W0102100304
EMDN description: THYROID STIMULATING IMMUNOGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:41

Manufacturer products View details

HOKAPI™ ANTI-TPO

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390434871
Basic UDI-DI: 697139043030983
Reference: 010309401
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ ANTI-TPO

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390434888
Basic UDI-DI: 697139043030983
Reference: 010305101
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ ANTI-TG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439807
Basic UDI-DI: 69713904303087Z
Reference: 010308101
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-TG Calibrators

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577176967
Basic UDI-DI: 697015090000022GS
Reference: CA120501
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-TPO Calibrators

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177384
Basic UDI-DI: 697015090000023GU
Reference: CA120101
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

TRAb CLIA Microparticles

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177780
Basic UDI-DI: 697015090000118H8
Reference: CME1002
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

TRAb CLIA Microparticles

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178169
Basic UDI-DI: 697015090000118H8
Reference: CME1001
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231106
Basic UDI-DI: 697846523autoAbsB01QN
Reference: 2×50 test
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Antibodies to Thyroid Peroxidase Assay kit(Chemiluminescence Immunoassay Method）

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231205
Basic UDI-DI: 697846523autoAbsB02QQ
Reference: 2×50 test
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236767
Basic UDI-DI: 697846523autoAbsB01QN
Reference: 25 tests
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236774
Basic UDI-DI: 697846523autoAbsB01QN
Reference: 50 tests
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236781
Basic UDI-DI: 697846523autoAbsB01QN
Reference: 100 tests
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Antibodies to Thyroid Peroxidase Assay kit(Chemiluminescence Immunoassay Method）

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236798
Basic UDI-DI: 697846523autoAbsB02QQ
Reference: 25 tests
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Antibodies to Thyroid Peroxidase Assay kit(Chemiluminescence Immunoassay Method）

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236804
Basic UDI-DI: 697846523autoAbsB02QQ
Reference: 50 tests
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Antibodies to Thyroid Peroxidase Assay kit(Chemiluminescence Immunoassay Method）

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465236811
Basic UDI-DI: 697846523autoAbsB02QQ
Reference: 100 tests
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: HyperCert Limited B.V.
Last updated: 16.06.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

EliA anti-TSH-R Curve Control Strips

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015255
Basic UDI-DI: 7333066BUDI0061M2
Reference: 83-1112-01
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:30

Manufacturer products View details