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01.08.2026 18:27

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102 device results listed.

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++B261CANATP4160X6

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANATP4160X6
Basic UDI-DI: B-++B261CANATP4160X6
Reference: CAN-ATP-4160
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroid peroxidase test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406924
Basic UDI-DI: 697029753461LS
Reference: HGCL69
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO 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: 06942359541961
Basic UDI-DI: 697015090000023GU
Reference: CME0703
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroid peroxidase(CLIA)

105-005665-00、105-005682-00、105-005916-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065274
Basic UDI-DI: 69449040004L-Anti-TPO**6B
Reference: 105-005665-00
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-TPO

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715313
Basic UDI-DI: 692591270009H3
Reference: C89004G-L
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S anti-TPOn KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632172
Basic UDI-DI: 426015763852BantTPOnKXX2Q
Reference: 852075N
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

VIDAS® Anti-TPO

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026327460
Basic UDI-DI: 357302BUDI000093TB
Reference: 30461
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

Anti-TPO RIA KIT

Immunoassay, A56719

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590205348
Basic UDI-DI: 150995905A56719TZ
Reference: A56719
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

LIAISON® Anti-TPO

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200301
Basic UDI-DI: B-08056771200301
Reference: 311701
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

SmarLumi

Antibody to Thyroid Peroxidase (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852395
Basic UDI-DI: B-06933289852395
Reference: WA47P0006
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Antibody to Thyroid Peroxidase (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852364
Basic UDI-DI: B-06933289852364
Reference: WA47P0003
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Antibody to Thyroid Peroxidase (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852388
Basic UDI-DI: B-06933289852388
Reference: WA47P0005
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Antibody to Thyroid Peroxidase (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852371
Basic UDI-DI: B-06933289852371
Reference: WA47P0004
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid peroxidase antibody (Anti-TPO) Diagnostic Kit（Immunochromatographic Assay）

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765590
Basic UDI-DI: B-06971348765590
Reference: MF-121-25
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid peroxidase antibody (Anti-TPO) Diagnostic Kit（Immunochromatographic Assay）

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762094
Basic UDI-DI: B-06971348762094
Reference: MF-121-20
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Anti-TPO Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TPO Ab

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962153
Basic UDI-DI: 0405686901370VE
Reference: 10381649
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608570
Basic UDI-DI: 0405686902269VX
Reference: 11206075
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti-Thyroid Peroxidase II (aTPOII)

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608761
Basic UDI-DI: 0405686902269VX
Reference: 11206077
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608747
Basic UDI-DI: 0405686902269VX
Reference: 11206074
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1341528

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1341528
Basic UDI-DI: B-R1341528
Reference: R13415
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details