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Sodium Fluoride / EDTA.Na2 (Glucose Tube）2ml

by Jiangxi Exquisite Technology Co., Ltd.

Ref B01SF002Model Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, 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 Number697656048BCT01KP Basic UDI-DI 06976560481761UDI-DIDate12 Jan 2026RegisteredStatusActive

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  • Withdrawn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
Blood Collection Tube For Single-Use
Model / Reference
Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc, B01SF002
Primary DI / UDI-DI
06976560481761
Basic UDI-DI
697656048BCT01KP
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000038653
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No