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DiaTrust

by DiaTrust Medical Co., Ltd EUDAMED

Active European Union

Ref LC02-0108Model CL03,EC01,EC02,EC03,EC04,EC05,EC06,EC07,EC09,EC10,EC13,EC15,EC16,EC180,EC18,EC181,EC185,EC19,EC196,EC20,EC23,EC28,EC92,EC93,EC94,EC96.

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6974570461012BG Basic UDI-DIDate29 Jun 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  • Withdrawn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
Tissue Cassettes
Model / Reference
CL03, EC01, EC02, EC03, EC04, EC05, EC06, EC07, EC09, EC10, EC13, EC15, EC16, EC180, EC18, EC181, EC185, EC19, EC196, EC20, EC23, EC28, EC92, EC93, EC94, EC96., LC02-0108
Primary DI / UDI-DI
06936700726367
Basic UDI-DI
6974570461012BG
Direct Marketing DI
06936700726367
EMDN Code
W05030501 Inclusion devices, cassettes
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