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iStar-Anti-TPO

by Shenzhen Drawray Biotech Co., Ltd.

Ref DC76054Model 30 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732248900209Y Basic UDI-DI 06973224892451UDI-DIDate26 Feb 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
iStar-Anti-TPO
Model / Reference
30 Tests/kit, DC76054
Primary DI / UDI-DI
06973224892451
Basic UDI-DI
69732248900209Y
EMDN Code
W0102100301 Thyroid peroxidase (incl. microsomal) antibodies
Device Class
Class B
EU market of registration
Netherlands

Manufacturer details

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

Other devices from Shenzhen Drawray Biotech Co., Ltd.

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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