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DiaTrust

by DiaTrust Medical Co., Ltd EUDAMED

Active European Union

Ref SC01-1026Model SC00,SC01,SC02,SC03,SC13,SC310,SC510,SC511,SC515,SC520,SC521,SC525,SC531,SC610,SC620,SC630,SC640

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6974570461021BH Basic UDI-DIDate28 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR 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
Histology Storage System
Model / Reference
SC00, SC01, SC02, SC03, SC13, SC310, SC510, SC511, SC515, SC520, SC521, SC525, SC531, SC610, SC620, SC630, SC640, SC01-1026
Primary DI / UDI-DI
06974570468734
Basic UDI-DI
6974570461021BH
Direct Marketing DI
06974570468734
EMDN Code
W0202059099 Various processing instruments for hystology / cytology - other
Device Class
Class I
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

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No