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Digital Ultra Early & Weeks Indicator Pregnancy Tests

by SPD Swiss Precision Diagnostics GmbH

Ref 08006530600859Model CB9/CB15

Active European Union

CE IVDR

Valid until

3 Sep 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 099371 0036 Date4 Sep 2026IssuedStatusActive expires 3 Sep 2031

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  • Withdrawn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
CB9/CB15, 08006530600859
Primary DI / UDI-DI
08006530600859
Basic UDI-DI
4084500CB9/CB15XD
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CH-MF-000025175
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Animal Tissues
  • Self Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No