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Hebei Free Trade Zone Shenghong Medical Devices Co., Ltd

by Hebei Free Trade Zone Shenghong Medical Devices Co., Ltd 10 variants

Ref EDTA K2Model Plain Tube（No Additive）; Clot Activator Tube(Pro-coagulation); Gel&Clot Activator; EDTA K3; EDTA K2; PT Tube (Sodium Citrate 9NC); ESR Tube (Sodium Citrate 4NC); Heparin Lithium; Heparin Sodium; Sodium fluoride/ Potassium Oxalate; 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697666364CXG001RC Basic UDI-DI 06976663640058UDI-DIDate17 Aug 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  • Withdrawn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
Single-use Container For Human Venous Blood Specimen Collection
Model / Reference
Plain Tube（No Additive）, Clot Activator Tube(Pro-coagulation), Gel&Clot Activator, EDTA K3, EDTA K2, PT Tube (Sodium Citrate 9NC), ESR Tube (Sodium Citrate 4NC), Heparin Lithium, Heparin Sodium, Sodium fluoride/ Potassium Oxalate, etc
Primary DI / UDI-DI
06976663640058
Basic UDI-DI
697666364CXG001RC
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-000030893
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