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BIOGEMA TEST HEMOGLOBÍN 3v1

by W.H.P.M. Bioresearch & Technology Co., Ltd.

Ref 1030Model Cassette

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10309F Basic UDI-DI D-10309FUDI-DIDate13 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Occult Blood Tests
Model / Reference
Cassette, 1030
Primary DI / UDI-DI
D-10309F
Basic UDI-DI
B-10309F
EMDN Code
W0102160203 Fecal occult blood - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
CN-MF-000003007
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from W.H.P.M. Bioresearch & Technology Co., Ltd.

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Properties

  • Reagent
  • Self Testing

Other properties (8)

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