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Octo Health Real Time Pcr Fmf Panel Kit 2

by Octo Biyoteknoloji Arge Sanayi ve Ticaret Anonim Şirketi 2 variants

Ref RT-FMF-P2-50

Active European Union

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08685185072350 Basic UDI-DI 08685185072350UDI-DIDate2 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
RT-FMF-P2-50
Primary DI / UDI-DI
08685185072350
Basic UDI-DI
B-08685185072350
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TR-MF-000053054

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Properties

  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No