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Disposable Vacuum Blood Collection Tubes

by suzhou lingyan medical technology Co., ltd EUDAMED

Active European Union

Ref coagulant tubes (clot activator), Plain tube(without additives), separation gel rube(Gel & activator)Model "Plain tube(without additives);anticoagulant tubes(EDTA-K2,EDTA-K3,sod ium citrate 1:4,sodium citrate 1:9,heparin sodium,heparin lithium,Glucose tube Florude); coagulant tube(Clot activator);separation gel tube(Gel&activator)"

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697369694LY01US Basic UDI-DIDate19 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Disposable Vacuum Blood Collection Tubes
Model / Reference
"Plain tube(without additives), anticoagulant tubes(EDTA-K2, EDTA-K3, sod ium citrate 1:4, sodium citrate 1:9, heparin sodium, heparin lithium, Glucose tube Florude), coagulant tube(Clot activator), separation gel tube(Gel&activator)", coagulant tubes (clot activator), Plain tube(without additives), separation gel rube(Gel & activator)
Primary DI / UDI-DI
06973696949097, 06973696949011, 06973696949103
Basic UDI-DI
697369694LY01US
EMDN Code
W050101010202, W050101010201
Device Class
Class A
Market of Registration
Türkiye
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044639
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