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FOB Fecal Occult Blood Rapid Test

by Shanghai Chemtron Biotech Co., Ltd. 14 variants

Ref 9001T61SN20Model Cassette, Tube

Active European Union

CE IVDR

Valid until

8 Oct 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 076482 0014 Date9 Oct 2026IssuedStatusActive expires 8 Oct 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Cassette, Tube, 9001T61SN20
Primary DI / UDI-DI
06977775222460
Basic UDI-DI
693869769001RR
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class C
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shanghai Chemtron Biotech Co., Ltd.

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Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No