Skip to content

Fecal Occult Blood (FOB) Test

by Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. 14 variants

Ref TIHHB02001

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08693285187751 Basic UDI-DI 08693285187751UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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
Fecal Occult Blood (FOB) Test
Model / Reference
TIHHB02001
Primary DI / UDI-DI
08693285187751
Basic UDI-DI
B-08693285187751
EMDN Code
W0102160203 Fecal occult blood - rt & poc
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000028553

Other devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.

See all devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. →

Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

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