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FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)

by Genekam Biotechnology AG EUDAMED

Active European Union

Ref FR475

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262420430676 Basic UDI-DIDate30 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
FR475
Primary DI / UDI-DI
04262420430676
Basic UDI-DI
B-04262420430676
EMDN Code
W0105040519
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000035227

Other devices from Genekam Biotechnology AG

See all devices from Genekam Biotechnology AG →

Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No