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Ultra Early Advanced Pregnancy Test

by SPD Swiss Precision Diagnostics GmbH EUDAMED

Active European Union

Ref 08006530242851Model CB16

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV74 099371 0023 Date2 Jul 2026IssuedStatusActive expires 18 Feb 2030

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  • Withdrawn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 0023 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    2 Jul 2026
    Expires
    18 Feb 2030
    Reason
    Change approved

Specification

EUDAMED

Device Name
Ultra Early Advanced Pregnancy Test, Early Detection Advanced Pregnancy Test, Dual Hormone Pregnancy Test
Model / Reference
CB16, 08006530242851
Primary DI / UDI-DI
08006530242851
Basic UDI-DI
4084500CB16QX
Unit of Use DI
00633472000584
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
  • 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