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FOB Rapid Test Cassette (Colloidal Gold Method)

by Hangzhou Fanttest Biotech Co., Ltd. EUDAMED

Active European Union

Ref TFO-602Model 25 tests/kit

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974408023555 Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
FOB Rapid Test Cassette (Colloidal Gold Method)
Model / Reference
25 tests/kit, TFO-602
Primary DI / UDI-DI
06974408023555
Basic UDI-DI
B-06974408023555
EMDN Code
W0102039013 Fecal occult blood (ic)
Device Class
Class IVD General
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000026134
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No