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Vacuum Blood Collection Tube

by Zhejiang Skg Medical Technology Co., Ltd China EUDAMED

Ref Plain 2mlModel Plain, EDTA K3, EDTA K2, Clot Activator, Gel+Clot Activator, 3.8% Sodium Citrate, 3.2% Sodium Citrate, Heparin Sodium, Heparin Lithium, ACD Solution A, ACD Solution B,EDTA K2+Gel, EDTA K3+ Gel, Cell-free DNA, Potassium Oxalate +Sodium Fluoride, etc

EMDN W050101010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697527629VBCT0012B Basic UDI-DIDate22 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Vacuum Blood Collection Tube
Model / Reference
Plain, EDTA K3, EDTA K2, Clot Activator, Gel+Clot Activator, 3.8% Sodium Citrate, 3.2% Sodium Citrate, Heparin Sodium, Heparin Lithium, ACD Solution A, ACD Solution B,EDTA K2+Gel, EDTA K3+ Gel, Cell-free DNA, Potassium Oxalate +Sodium Fluoride, etc, Plain 2ml
Primary DI / UDI-DI
06975276290094
Basic UDI-DI
697527629VBCT0012B
EMDN Code
W050101010101 Blood collection, closed syringes with additives
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023027
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 48d14a0a-94d1-4fa3-8276-72bd87eef3c1 61 fields · synced 22 Oct 2026