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Pct

by Shenzhen Drawray Biotech Co., Ltd. China EUDAMED

Ref DT0163Model 5 tests/kit

EMDN W0102060309,W0102069013

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DT01637F Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
5 tests/kit, DT0163
Primary DI / UDI-DI
D-DT01637F
Basic UDI-DI
B-DT01637F
EMDN Code
W0102060309,W0102069013
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Medunion S.L. ES-AR-000019366

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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-DT01637F|B-DT01637F 61 fields · synced 24 Oct 2026