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Clearblue Test di gravidanza Rilevazione Precoce

by SPD Swiss Precision Diagnostics GmbH 4 variants

Ref 08700216528580Model CB14

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

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 NumberV76 099371 0030 Date29 Oct 2025IssuedStatusWithdrawn No longer placed on the EU market expires 27 Oct 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 099371 0030 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    29 Oct 2025
    Expires
    27 Oct 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
Clearblue Ultra Early Pregnancy Test, Clearblue Pregnancy Test Ultra Early
Model / Reference
CB14, 08700216528580
Primary DI / UDI-DI
08700216528580
Basic UDI-DI
4084500CB14QT
Unit of Use DI
00633472000416
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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Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (8)

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