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FR799

by Genekam Biotechnology AG Germany EUDAMED

Ref FR799

EMDN W0105080908

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number426242043GEN222SR Basic UDI-DIDate25 Jun 2024RegisteredStatusActive
European UnionCE/IVDR Number426242043GEN222SR Basic UDI-DIDate25 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
FR799
FR799-Identification of human specific ß-Actin
Model / Reference
FR799
Primary DI / UDI-DI
04262420430010
Basic UDI-DI
426242043GEN222SR, B-04262420430010
Direct Marketing DI
04262420430010
EMDN Code
W0105080908 Standards and calibrators for all infections/ nat
Device Class
Class A
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 & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED dfc2c255-fdce-4adc-87dc-adc1b623cf1e 61 fields · synced 22 Oct 2026
  • EUDAMED 04262420430010|B-04262420430010 61 fields · synced 18 May 2026