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242 device results listed.

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iFlash-SS-A IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720393
Basic UDI-DI: 692591270066HF
Reference: C89011G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PCNA IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720232
Basic UDI-DI: 692591270264HM
Reference: C86108
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Sm IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717867
Basic UDI-DI: 692591270064HB
Reference: C89010G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Scl-70 IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717225
Basic UDI-DI: 692591270068HK
Reference: C89013G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Jo-1 IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717119
Basic UDI-DI: 692591270067HH
Reference: C89014G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SS-B IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717102
Basic UDI-DI: 692591270063H9
Reference: C89012G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416409
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02197C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Theresa RUO Kit

Theresa RUO kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Navolab Diagnosztika Kft
Manufacturer SRN: HU-MF-000025337
UDI-DI: 05999862454005
Basic UDI-DI: 599986245415L
Reference: TK-0001
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BlueDiverDot Gastritis IgG

BlueDiverDot Gastritis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681473
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: IFPCADIV-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Gastritis IgG

BlueDot Gastritis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680469
Basic UDI-DI: 542502368BDGASTRITISLY
Reference: IFPCAD-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

MESACUP TypeVII Collagen TEST

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506018448
Basic UDI-DI: 498750601844KG
Reference: 7846E
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-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