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FOB Fast Test Kit (Immunofluorescence Assay)

by Getein Biotech, Inc. China EUDAMED

Ref IF2042 EMDN W0102160203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number695441470234H7 Basic UDI-DIDate24 Aug 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  • Withdrawn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 24 Oct 2026

Model / Reference
IF2042
Primary DI / UDI-DI
06954414736670
Basic UDI-DI
695441470234H7
EMDN Code
W0102160203 Fecal occult blood - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000017986
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Getein Biotech, Inc

See all devices from Getein Biotech, Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06954414736670|695441470234H7 61 fields · synced 24 Oct 2026