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Unicorn-hs-cTnI

by Shenzhen Drawray Biotech Co., Ltd.

Ref DT0001, DT0065Model 5 Tests/kit; 20 Tests/kit, 5 Tests/kit, 20 Tests/kit

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6973224890067AS Basic UDI-DI Date29 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
5 Tests/kit, 20 Tests/kit, DT0001, DT0065
Primary DI / UDI-DI
06973224897388, 06973224897395, D-DT00657E, D-DT00016L
Basic UDI-DI
6973224890067AS, B-DT00657E, B-DT00016L
EMDN Code
W01021306 Troponin i/t
Device Class
Class C
Class IVD General
EU market of registration
Netherlands
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Drawray Biotech Co., Ltd.

See all devices from Shenzhen Drawray Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No