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Vacuum Blood Collection Tubes

by Shandong Aosaite Medical Devices Co., Ltd. 75 variants

Ref EDTAK3 (3ml)Model EDTAK3 (2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml)

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697374904DVBCT006B6 Basic UDI-DI 06973749041372UDI-DIDate27 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Vacuum Blood Collection Tubes
Model / Reference
EDTAK3 (2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml), EDTAK3 (3ml)
Primary DI / UDI-DI
06973749041372
Basic UDI-DI
697374904DVBCT006B6
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-000010956
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Aosaite Medical Devices Co., Ltd.

See all devices from Shandong Aosaite Medical Devices Co., Ltd. →

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