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FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

by Genekam Biotechnology AG Germany EUDAMED

Ref FR118 EMDN W0105080908

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426242043GEN111SF Basic UDI-DIDate27 Sep 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
FR118
Primary DI / UDI-DI
04262420430225
Basic UDI-DI
426242043GEN111SF
Direct Marketing DI
04262420430225
EMDN Code
W0105080908 Standards and calibrators for all infections/ nat
Device Class
Class A
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 (1)

  • EUDAMED 541923ae-e376-4b31-965a-340c343b0aaa 61 fields · synced 22 Oct 2026