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GlutenCHECK

by NanoRepro AG Germany EUDAMED

Ref 400620

EMDN W01021699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-400620MF Basic UDI-DIDate11 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
400620
Primary DI / UDI-DI
D-400620MF
Basic UDI-DI
B-400620MF
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD devices for self-testing
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
DE-MF-000023735

Other devices from NanoRepro AG

See all devices from NanoRepro AG →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 164d2ec1-c681-4710-855f-2837573415de 61 fields · synced 22 Oct 2026