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NGSgo®-ProntoAmp

by Genome Diagnostics B.V. Netherlands EUDAMED

Ref 9903613 EMDN W01030499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871846936prontoampBV Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
NGS-Pronto®
Model / Reference
9903613
Primary DI / UDI-DI
08718469362905
Basic UDI-DI
871846936prontoampBV
Direct Marketing DI
08718469362905
EMDN Code
W01030499 Tissue typing reagents - other
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000453

Other devices from Genome Diagnostics B.V.

See all devices from Genome Diagnostics B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08718469362905|871846936PRONTOAMPBV 61 fields · synced 25 Oct 2026