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ParaGENIE Crypto-Micro Real Time PCR kit

by Ademtech France EUDAMED

Ref 60405 EMDN W0105070504

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number377004141960405CF Basic UDI-DIDate24 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
ParaGENIE Crypto-Micro Real Time PCR kit
Model / Reference
60405
Primary DI / UDI-DI
03770041419037
Basic UDI-DI
377004141960405CF
EMDN Code
W0105070504 Gastrointestinal infections - multiplex na reagents
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000048678

Other devices from Ademtech

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a8230f52-02d1-484c-a877-5784dc71f64a 61 fields · synced 25 Oct 2026