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12 x GFX saliva collectors (includes funnel, tube filled with 1ml stabilization buffer, cap & instruction manual)

by Cell Projects Ltd

Ref GFX-01/12Model GeneFix DNA/RNA Collector, Non-Sterile

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 Number506054410Genefix8M Basic UDI-DI 05060544100012UDI-DIDate21 Aug 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  • Withdrawn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

Device Name
GeneFix DNA/RNA Collector, Non-sterile
Model / Reference
GeneFix DNA/RNA Collector, Non-Sterile, GFX-01/12
Primary DI / UDI-DI
05060544100012
Basic UDI-DI
506054410Genefix8M
Direct Marketing DI
05060544100012
EMDN Code
W05019002 Saliva collection devices
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
GB-MF-000002266
Authorised representative
Advena Limited MT-AR-000000234

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See all devices from Cell Projects Ltd →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • 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