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Disposable vacuum blood collection tube

by Shenyang Bokan Biotechnology Co., Ltd

Ref BK7189NC2Model "Red blood collection glass tube（no needle） BKG720Z.BKG730Z.BKG740Z.BKG1020Z.BKG1030Z.BKG1040Z. BKG1050Z.BKG1060Z. BKG1070Z. BKG1080Z.BKG1090Z.BKG10100Z,or customized" etc

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697364285BKDVBCTXY Basic UDI-DI 06973642851870UDI-DIDate27 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Disposable vacuum blood collection tube
Model / Reference
"Red blood collection glass tube（no needle） BKG720Z.BKG730Z.BKG740Z.BKG1020Z.BKG1030Z.BKG1040Z. BKG1050Z.BKG1060Z. BKG1070Z. BKG1080Z.BKG1090Z.BKG10100Z, or customized" etc, BK7189NC2
Primary DI / UDI-DI
06973642851870
Basic UDI-DI
697364285BKDVBCTXY
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046050
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • 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