Skip to content

First Praedict TEST DI GRAVIDANZA PRECOCE

by PRIMA Lab SA EUDAMED

Active European Union

Ref HGEH8FP00KIT02IT

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  • Withdrawn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

Device Name
Early Detection Pregnancy Test
Model / Reference
HGEH8FP00KIT02IT
Primary DI / UDI-DI
07640164861715
Basic UDI-DI
764016486HGEH8B6
Direct Marketing DI
07640164861715
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
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

Show 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