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SANAVITA TEST Gravidanza - EARLY DETECTION PREGNANCY TEST

by PRIMA Lab SA

Ref HGEH8SV00KIT01IT

Active European Union

CE IVDR

Valid until

25 Oct 2028

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier mdc medical device certification GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberD1408400113 Date14 Jul 2026IssuedStatusActive expires 25 Oct 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1408400113 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    mdc medical device certification GmbH 0483
    Issued
    14 Jul 2026
    Expires
    25 Oct 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Early Detection Pregnancy Test
Model / Reference
HGEH8SV00KIT01IT
Primary DI / UDI-DI
07640164861661
Basic UDI-DI
764016486HGEH8B6
Direct Marketing DI
07640164861661
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000034473
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from PRIMA Lab SA

See all devices from PRIMA Lab SA →

Properties

  • Self Testing

Other properties (10)

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