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Ultra Early & Weeks Indicator Pregnancy Tests

by SPD Swiss Precision Diagnostics GmbH 3 variants

Ref 08006530340786Model CB14/CB9A

Active European Union

CE IVDR

Valid until

25 Feb 2030

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4084500CB14/CB9TL Basic UDI-DI 08006530340786UDI-DIDate10 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V74 099371 0022 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    12 Mar 2026
    Expires
    25 Feb 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
CB14/CB9A, 08006530340786
Primary DI / UDI-DI
08006530340786
Basic UDI-DI
4084500CB14/CB9TL
Unit of Use DI
00633472000430
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

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

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Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Surgical Instrument

Other properties (7)

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