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Rapid Fecal Occult Blood Test Card

by Xiamen Boson Biotech Co., Ltd. 10 variants

Ref 1M01C4-B2-CE

Active European Union

CE IVDR

Valid until

23 Jun 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 Number692196371613J5 Basic UDI-DI Date14 Jul 2026RegisteredStatusActive

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  • Withdrawn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
1M01C4-B2-CE
Primary DI / UDI-DI
06921963721518, 06921963721594, 06921963721433, 06921963721471, 06921963721495, 06921963721570, 06921963721457, 06921963721556, 06921963721532, 06921963721440
Basic UDI-DI
692196371613J5
Direct Marketing DI
06921963721518
06921963721594
06921963721433
06921963721471
06921963721495
06921963721570
06921963721457
06921963721556
06921963721532
06921963721440
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class C
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000001096
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Xiamen Boson Biotech Co., Ltd.

See all devices from Xiamen Boson Biotech Co., Ltd. →

Properties

  • Reagent
  • Self Testing
  • Professional Testing

Other properties (8)

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