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Biovac

by Biosci Healthcare 91 variants

Ref BVK2E08

Withdrawn No longer placed on the EU market

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8909085BCTKH Basic UDI-DIDate10 Jun 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
Biovac Vacuum Blood Collection Tube
Model / Reference
BVK2E08
Primary DI / UDI-DI
08909085001693
Basic UDI-DI
8909085BCTKH
EMDN Code
W050101010101 Blood collection, closed syringes with additives
Device Class
Class A

Manufacturer details

EUDAMED SRN
IN-MF-000052082
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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