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First Sign™ One-Step Immunological Hemoglobin and Transferrin Test

by W.H.P.M. Bioresearch & Technology Co., Ltd. 2 variants

Ref WH-FOB-S010402Model 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-WH-FOB-S010402F5 Basic UDI-DI D-WH-FOB-S010402F5UDI-DIDate15 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  • Withdrawn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, WH-FOB-S010402
Primary DI / UDI-DI
D-WH-FOB-S010402F5
Basic UDI-DI
B-WH-FOB-S010402F5
EMDN Code
W0102160203 Fecal occult blood - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Germany

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