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NG Precision+

by NG Biotech SAS France EUDAMED

Ref NGB-HCG-W21-016 EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number37010774PRECISIONPL_OTCU8 Basic UDI-DIDate10 Oct 2023RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Withdrawn

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 · synced 23 Oct 2026

Model / Reference
NGB-HCG-W21-016
Primary DI / UDI-DI
03701077401888
Basic UDI-DI
37010774PRECISIONPL_OTCU8
Direct Marketing DI
03701077401888
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B

Manufacturer details

EUDAMED SRN
FR-MF-000016216

Other devices from NG Biotech SAS

See all devices from NG Biotech SAS →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 03701077401888|37010774PRECISIONPL_OTCU8 61 fields · synced 23 Oct 2026