Skip to content

ZuhauseTEST Bowel Health (FOB) Rapid Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd.

Ref 600400

Active European Union

CE IVDR

Valid until

11 Aug 2030

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 095123 0020 Date23 Jun 2026IssuedStatusActive expires 11 Aug 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 095123 0020 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    23 Jun 2026
    Expires
    11 Aug 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
One+Step Bowel Health (FOB) Rapid Test
Model / Reference
600400
Primary DI / UDI-DI
06936983199452
Basic UDI-DI
6970277510014RYW
EMDN Code
W0101060399 Faeces tests - rapid tests and "point of care" - other
Device Class
Class C
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties

  • Human Tissues
  • Reagent
  • Self Testing

Other properties (8)

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