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04987506016826

MESACUP-2 TEST Desmoglein 1

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016826
Basic UDI-DI: 498750601682KE
Reference: 7881E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016819

MESACUP BP180 TEST

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016819
Basic UDI-DI: 498750601681KC
Reference: 7697E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016802

MESACUP BP230 TEST

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016802
Basic UDI-DI: 498750601680KA
Reference: 7614E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

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

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B·R·A·H·M·S anti-Tgn KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632097
Basic UDI-DI: 426015763830BantiTgnKXXEH
Reference: 830075N
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

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B·R·A·H·M·S TRAK human KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631823
Basic UDI-DI: 426015763801BTRAKhumKXXMX
Reference: 801050N
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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