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DiaTrust

by DiaTrust Medical Co., Ltd EUDAMED

Active European Union

Ref TG13-1352Model CT210,CT220,CT310,CT320,CT410,CT420,CT510,CT511,FC000,FC001,FC002,FC201,FC202,FC203,FC204,FC320,FC324,FC325,FC326,FC340,FC360,FC390,RS01,SC0501,SC0601,SC0602,SC0603,SC0604,SC0605,SC0701,SC0702,SC0703,SC0704,SC0705,SC0706,SC0707,SC0801

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6974570461017BS 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  • Withdrawn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
Non-Sterile Specimen Container
Model / Reference
CT210, CT220, CT310, CT320, CT410, CT420, CT510, CT511, FC000, FC001, FC002, FC201, FC202, FC203, FC204, FC320, FC324, FC325, FC326, FC340, FC360, FC390, RS01, SC0501, SC0601, SC0602, SC0603, SC0604, SC0605, SC0701, SC0702, SC0703, SC0704, SC0705, SC0706, SC0707, SC0801, TG13-1352
Primary DI / UDI-DI
06936700769371
Basic UDI-DI
6974570461017BS
Direct Marketing DI
06936700769371
EMDN Code
W0503010101 Samples analyses, glass tubes
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