Skip to content

Clearblue Schwangerschaftstest mit Wochenbestimmung

by SPD Swiss Precision Diagnostics GmbH 4 variants

Ref 05011321593008Model CB9

Active European Union

CE IVDR

Valid until

31 Jul 2029

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 Number4084500CB985 Basic UDI-DI 05011321593008UDI-DIDate11 Apr 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Clearblue Pregnancy Test with Weeks Indicator
Model / Reference
CB9, 05011321593008
Primary DI / UDI-DI
05011321593008
Basic UDI-DI
4084500CB985
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Austria

Manufacturer details

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

Other devices from Spd Swiss Precision Diagnostics GmbH

See all devices from Spd Swiss Precision Diagnostics GmbH →

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