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308 device results listed.

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Anti-Integrin αvβ6 ELISA Kit (IVD)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506018417
Basic UDI-DI: 498750601841KA
Reference: 7670E
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

04987506016833

MESACUP-2 TEST Desmoglein 3

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

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016833
Basic UDI-DI: 498750601683KG
Reference: 7886E
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

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

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

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

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 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

INDICAID™ Anti-ovarian Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A036D4
Basic UDI-DI: B-A036D4
Reference: INDICAID™ Anti-ovarian Antibody Test
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® tTG IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200882
Basic UDI-DI: B-08056771200882
Reference: 310320
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

D-A5093

INDICAID™ Antisperm Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5093
Basic UDI-DI: B-A5093
Reference: INDICAID™ Antisperm Antibody Test
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Diagnostic Screening Test for Sperm Concentration

cassette

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990302PS
Basic UDI-DI: B-693757990302PS
Reference: JZMD cassette
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-116FF

Anti-Trophoblast cell membrane antibody Assay Kit (Chemiluminescent Microparticle Immunoassay)