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FOB One Step Fecal Occult Blood Test Device (Feces)

by Abon Biopharm(Hangzhou) Co., Ltd

Ref TFO-602

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06952999408944 Basic UDI-DI Date25 Nov 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
FOB One Step Fecal Occult Blood Test Device (Feces)
Model / Reference
TFO-602
Primary DI / UDI-DI
06952999408944, 06952999408937
Basic UDI-DI
B-06952999408944, B-06952999408937
EMDN Code
W0102160203 Fecal occult blood - rt & poc
Device Class
Class IVD General
EU market of registration
Netherlands
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009171
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Abon Biopharm(Hangzhou) Co., Ltd

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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