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NGSgo®-AmpX v2 HLA-A

by Genome Diagnostics B.V. Netherlands EUDAMED

Ref 7970162 EMDN W01030499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871846936ngsgo-ampxv2F4 Basic UDI-DIDate4 Dec 2023RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
NGSgo®-AmpX v2
Model / Reference
7970162
Primary DI / UDI-DI
08718469369287
Basic UDI-DI
871846936ngsgo-ampxv2F4
Direct Marketing DI
08718469369287
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 ad839610-93ae-4394-b45f-a432a42c095e 61 fields · synced 24 Oct 2026