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Disposable Vacuum Blood Collection Tube

by Henan Tuoren Medical Technology Co., Ltd. 425 variants

Ref BTSGJ10Model K2EDTA

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697575459086R7 Basic UDI-DI 06975754594461UDI-DIDate15 Jan 2023RegisteredStatusActive

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  • Withdrawn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
K2EDTA, BTSGJ10
Primary DI / UDI-DI
06975754594461
Basic UDI-DI
697575459086R7
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

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

Other devices from Henan Tuoren Medical Technology Co., Ltd.

See all devices from Henan Tuoren Medical Technology Co., Ltd. →

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