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Clearblue Test di gravidanza Rilevazione Digitale Precoce

by SPD Swiss Precision Diagnostics GmbH

Ref 08001841704265Model CB15

Active European Union

CE IVDR

Valid until

13 Aug 2028

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4084500CB15QV Basic UDI-DI 08001841704265UDI-DIDate3 Mar 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  • Withdrawn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 Digital Ultra Early Pregnancy Test
Model / Reference
CB15, 08001841704265
Primary DI / UDI-DI
08001841704265
Basic UDI-DI
4084500CB15QV
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Italy

Manufacturer details

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

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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