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GlutenCHECK

by NanoRepro AG Germany EUDAMED

Ref 400630

EMDN W01021699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-400630MJ 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 24 Oct 2026

Model / Reference
400630
Primary DI / UDI-DI
D-400630MJ
Basic UDI-DI
B-400630MJ
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD devices for self-testing
Market of Registration
Slovenia

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 c765f6e4-9c3e-4d38-afa6-7e03181d97b7 61 fields · synced 24 Oct 2026