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BIOSYNEX Zelftest gluten

by Biosynex France EUDAMED

Ref 860759 EMDN W0102100604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03532678607597 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
BIOSYNEX Autotest Gluten
Model / Reference
860759
Primary DI / UDI-DI
03532678607597
Basic UDI-DI
B-03532678607597
EMDN Code
W0102100604 Gliadin antibodies
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0573e99d-5f49-41da-aa20-aef8a781442c 61 fields · synced 23 Oct 2026