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Clearblue Schwangerschaftstest Ultra Frühtest Digital

by SPD Swiss Precision Diagnostics GmbH 2 variants

Ref 8001841727721Model 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 08001841727721UDI-DIDate3 Mar 2025RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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, 8001841727721
Primary DI / UDI-DI
08001841727721
Basic UDI-DI
4084500CB15QV
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B

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