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DiaTrust

by DiaTrust Medical Co., Ltd EUDAMED

Active European Union

Ref FM100-118Model FM100,FM200,FM202,FM212,FM213,FM217

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6974570461089CK Basic UDI-DIDate28 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
O.C.T Compound
Model / Reference
FM100, FM200, FM202, FM212, FM213, FM217, FM100-118
Primary DI / UDI-DI
06936700781731
Basic UDI-DI
6974570461089CK
Direct Marketing DI
06936700781731
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000009279
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from DiaTrust Medical Co., Ltd

See all devices from DiaTrust Medical Co., Ltd →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances

Other properties (8)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No