Skip to content

res4plex direct RT-PCR

by FRIZ Biochem GmbH Germany EUDAMED

Ref FBC107Model Ax, Bx, Cx EMDN W0105070302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426075389fbc107U6 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Ax, Bx, Cx, FBC107
Primary DI / UDI-DI
04260753890150
Basic UDI-DI
426075389fbc107U6
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000017533

Other devices from FRIZ Biochem GmbH

See all devices from FRIZ Biochem GmbH →

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 (1)

  • EUDAMED df991a7e-39ba-4ba4-b706-33c285165ce6 61 fields · synced 23 Oct 2026