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Rapid Detection Pregnancy Test

by SPD Swiss Precision Diagnostics GmbH 3 variants

Ref 08700216287883Model CB11/CB11A

Active European Union

CE IVDR

Valid until

13 Jun 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V74 099371 0013 Active Supplemented

    Technical documentation EU IVDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Rapid Detection Pregnancy Test, Easy Pregnancy Test, Pregnancy Test Flip & Click
Model / Reference
CB11/CB11A, 08700216287883
Primary DI / UDI-DI
08700216287883
Basic UDI-DI
4084500CB11/CB11AUR
Unit of Use DI
00633472000065
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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See all devices from Spd Swiss Precision Diagnostics GmbH →

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