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NGSgo®-AmpX v2 HLAGeneSuite (11 loci)

by Genome Diagnostics B.V.

Ref 7971662

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871846936ngsgo-ampxv2F4 Basic UDI-DI 08718469369270UDI-DIDate4 Dec 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
NGSgo®-AmpX v2
Model / Reference
7971662
Primary DI / UDI-DI
08718469369270
Basic UDI-DI
871846936ngsgo-ampxv2F4
Direct Marketing DI
08718469369270
EMDN Code
W01030499 Tissue typing reagents - other
Device Class
Class C
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000453

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See all devices from Genome Diagnostics B.V. →

Properties

  • 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