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Disposable Sterile Evacuated Blood Collection Tubes

by Guangdong Ardent BioMed Co., Ltd. EUDAMED

Active European Union

Ref 245Model Fluoride EDTA.K2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697420809BCT006BX Basic UDI-DIDate9 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Fluoride EDTA.K2, 245
Primary DI / UDI-DI
06974208092454
Basic UDI-DI
697420809BCT006BX
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028102
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties

Show 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