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Vacuum Blood Collection Tubes

by Shandong Chengwu Yongkang Medical Products Co., Ltd. 50 variants

Ref Sodium citrate (1:4) 2mlModel No additives;Procoagulant;Procoagulant + Separation gel;Sodium citrate (1:4); Sodium citrate (1:9);Heparin sodium;Heparin lithium;EDTAK2;EDTAK3;Potassium oxalate

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697538157YK001P9 Basic UDI-DI 06975381571637UDI-DIDate13 Oct 2023RegisteredStatusActive

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  • Withdrawn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
Vacuum Blood Collection Tubes
Model / Reference
No additives;Procoagulant;Procoagulant + Separation gel;Sodium citrate (1:4); Sodium citrate (1:9);Heparin sodium;Heparin lithium;EDTAK2;EDTAK3;Potassium oxalate, Sodium citrate (1:4) 2ml
Primary DI / UDI-DI
06975381571637
Basic UDI-DI
697538157YK001P9
EMDN Code
W050101010101, W050101010102, W050101010201, W050101010202, W0501010103, W0501010180, W0501010199
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037682
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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