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Disposable Vacuum Blood Collection Tube

by Henan Tuoren Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref BTSPC05Model Coagulant/separation gel

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697575459079RA Basic UDI-DIDate4 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Coagulant/separation gel, BTSPC05
Primary DI / UDI-DI
26975754591969, 16975754591962
Basic UDI-DI
697575459079RA
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000017165
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Show properties
  • Sterile
  • Professional Testing
Other properties (9)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No