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VIDAS® Anti-Tg

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026327477
Basic UDI-DI: 357302BUDI000094TD
Reference: 30462
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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

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Anti-hTg IRMA KIT

Immunoassay, IM3223

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590218768
Basic UDI-DI: 150995905IM32235J
Reference: IM3223
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

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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

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Access Thyroglobulin Antibody II Reagent Pack

A32898

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590202910
Basic UDI-DI: 150995901AccTGAb3P
Reference: A32898
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Celiac Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OCEA-402AL
Basic UDI-DI: B-OCEA-402AL
Reference: OCEA-402
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76032GV7
Basic UDI-DI: B-DC76032GV7
Reference: DC76032G
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-MOG IIFT

FA 1156-50-R

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016162124
Basic UDI-DI: 4049016FA115650RSQ
Reference: FA 1156-2005-50-R
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:02

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NMOSD Mosaic 1 IIFT

FA 1128-1-R

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016162087
Basic UDI-DI: 4049016FA11281RTX
Reference: FA 1128-2005-1-R
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:02

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ANA (HEp-2) IIFT

FA 1520-R

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016160250
Basic UDI-DI: 4049016FA1520RZ2
Reference: FA 1520-1050-R
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:02

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Anti-MOG IIFT

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016162131
Basic UDI-DI: 4049016FA115650RSQ
Reference: FA 1156-2010-50-R
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:50

Manufacturer products View details

NMOSD Mosaic 1 IIFT

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016162094
Basic UDI-DI: 4049016FA11281RTX
Reference: FA 1128-2010-1-R
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:49

Manufacturer products View details

ANA (HEp-2) IIFT

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016160267
Basic UDI-DI: 4049016FA1520RZ2
Reference: FA 1520-12010-R
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:49

Manufacturer products View details

ANA (HEp-2) IIFT

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016160274
Basic UDI-DI: 4049016FA1520RZ2
Reference: FA 1520-2005-R
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:49

Manufacturer products View details

ANA (HEp-2) IIFT

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016160281
Basic UDI-DI: 4049016FA1520RZ2
Reference: FA 1520-2010-R
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:49

Manufacturer products View details

Anti-GBM

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147157500
Basic UDI-DI: B-86060147157500
Reference: N264A24GBM
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 hs

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147157050
Basic UDI-DI: B-86060147157050
Reference: N262A24PR3
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Anti Insulin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147156688
Basic UDI-DI: B-86060147156688
Reference: N281A24INS
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-MPO

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147156510
Basic UDI-DI: B-86060147156510
Reference: N263A24MPO
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details

ANCA-Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147154776
Basic UDI-DI: B-86060147154776
Reference: N261A24ACA
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details