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Afi

by AFI Centrifuge 19 variants

Ref AFI-C060R-E/IVD

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 Number376036988C060R-E2G Basic UDI-DI 03760369880022UDI-DIDate6 Sep 2022RegisteredStatusActive

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  • Withdrawn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
SIRENA Refrigerated Centrifuge, 230V IVD
Model / Reference
AFI-C060R-E/IVD
Primary DI / UDI-DI
03760369880022
Basic UDI-DI
376036988C060R-E2G
Direct Marketing DI
03760369880022
EMDN Code
W02069005 Refrigerated centrifuges
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001636

Other devices from AFI Centrifuge

See all devices from AFI Centrifuge →

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