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Digital Ultra Early Pregnancy Test

by SPD Swiss Precision Diagnostics GmbH EUDAMED

Active European Union

Ref 08001841804286Model CB15

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4084500CB15QV Basic UDI-DIDate3 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Clearblue Digital Ultra Early Pregnancy Test
Model / Reference
CB15, 08001841804286
Primary DI / UDI-DI
08001841804286
Basic UDI-DI
4084500CB15QV
Unit of Use DI
00633472000478
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Ireland

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