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Clearblue Test de sarcină Detectare rapidă

by SPD Swiss Precision Diagnostics GmbH EUDAMED

Active European Union

Ref 08001841301181Model CB11/CB11A

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV74 099371 0013 Date18 May 2026IssuedStatusActive expires 13 Jun 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V74 099371 0013 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    18 May 2026
    Expires
    13 Jun 2028
    Reason
    Change approved

Specification

EUDAMED

Device Name
Rapid Detection Pregnancy Test, Easy Pregnancy Test, Pregnancy Test Flip & Click
Model / Reference
CB11/CB11A, 08001841301181
Primary DI / UDI-DI
08001841301181
Basic UDI-DI
4084500CB11/CB11AUR
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Romania

Manufacturer details

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

Other devices from Spd Swiss Precision Diagnostics GmbH

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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