Skip to content

Candida Molecular Detection Kit (Real-time PCR)

by Genobio Pharmaceutical Co., Ltd. China EUDAMED

Ref FCAPCR-50 EMDN W0105060402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970514081052 Basic UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Candida Molecular Detection Kit (Real-time PCR)
Model / Reference
FCAPCR-50
Primary DI / UDI-DI
06970514081052
Basic UDI-DI
B-06970514081052
EMDN Code
W0105060402 Candida albicans - na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000027997
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Genobio Pharmaceutical Co., Ltd.

See all devices from Genobio Pharmaceutical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ca2106c9-faf4-4cb8-b667-d78d310531f5 61 fields · synced 24 Oct 2026