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iStar-Anti-TPO

by Shenzhen Drawray Biotech Co., Ltd. China EUDAMED

Ref DC76054Model 30 Tests EMDN W0102100301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DC76054FJ Basic UDI-DIDate24 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
30 Tests, DC76054
Primary DI / UDI-DI
D-DC76054FJ
Basic UDI-DI
B-DC76054FJ
EMDN Code
W0102100301 Thyroid peroxidase (incl. microsomal) antibodies
Device Class
Class IVD General
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.

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

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6d0a2939-fcf4-4a1d-b7cd-8853bf311275 61 fields · synced 24 Oct 2026