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Inuvi-004/CE Collection Kit

by Inuvi Health Limited

Ref Inuvi-004/CE

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5061107470177RU Basic UDI-DI 05061107470177UDI-DIDate15 Jul 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Inuvi-004/CE Collection Kit
Model / Reference
Inuvi-004/CE
Primary DI / UDI-DI
05061107470177
Basic UDI-DI
5061107470177RU
Direct Marketing DI
05061107470177
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000057167
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Inuvi Health Limited

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