Skip to content

Prima Home Test

by PRIMA Lab SA Switzerland EUDAMED

Ref HGEH88B00KIT01HU EMDN W0102160302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number764016486HGEH8B6 Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

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  • Withdrawn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)
  • D1408400113 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 0483
    Issued
    14 Jul 2026
    Expires
    25 Oct 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Early Detection Pregnancy Test
Model / Reference
HGEH88B00KIT01HU
Primary DI / UDI-DI
07640164861487
Basic UDI-DI
764016486HGEH8B6
Direct Marketing DI
07640164861487
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Hungary

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07640164861487|764016486HGEH8B6 61 fields · synced 24 Oct 2026