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Test de Grossesse Sanguin

by NG Biotech SAS EUDAMED

Active European Union

Ref NGB-HCG-W21-013

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberD1395900026 Date22 Jul 2026IssuedStatusActive expires 26 Mar 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  • Withdrawn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)
  • D1395900026 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 0483
    Issued
    22 Jul 2026
    Expires
    26 Mar 2030
    Reason
    Other

Specification

EUDAMED

Device Name
NG Precision+
Model / Reference
NGB-HCG-W21-013
Primary DI / UDI-DI
03701077401857
Basic UDI-DI
37010774PRECISIONPL_OTCU8
Direct Marketing DI
03701077401857
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
FR-MF-000016216

Other devices from NG Biotech SAS

See all devices from NG Biotech SAS →

Properties

Show properties
  • Animal Tissues
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No