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Rapid Fecal Occult Blood Test Card

by Xiamen Boson Biotech Co., Ltd. EUDAMED

Active European Union

Ref 1M01C4-2-CE

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692196371613J5 Basic UDI-DIDate14 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
1M01C4-2-CE
Primary DI / UDI-DI
06921963721525, 06921963721488, 06921963721600, 06921963721587, 06921963721501, 06921963721549, 06921963721563, 06921963721464
Basic UDI-DI
692196371613J5
Direct Marketing DI
06921963721525
06921963721488
06921963721600
06921963721587
06921963721501
06921963721549
06921963721563
06921963721464
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class C
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