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Venous Blood Collection Kit, Professional Use

by REAL Digital International Ltd

Ref KT10004-02

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50567516MDTF0053P5 Basic UDI-DI 05056751600933UDI-DIDate23 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
KT10004-02
Primary DI / UDI-DI
05056751600933
Basic UDI-DI
50567516MDTF0053P5
Direct Marketing DI
05056751600933
EMDN Code
W0501010199 Venous or arterious blood collection devices - other
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000039088
Authorised representative
Casus Europe B.V. NL-AR-000037688

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Properties

  • New Device

Other properties (10)

  • 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