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NovaLisa® Herpes simplex Virus 2 (HSV 2) IgM

by Gold Standard Diagnostics Frankfurt GmbH EUDAMED

Active European Union

Ref HSV2M054DS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-+ENTIHSV2M054DS0H Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
NovaLisa® Herpes simplex Virus 2 (HSV 2) IgM
Model / Reference
HSV2M054DS
Primary DI / UDI-DI
+ENTIHSV2M054DS0H
Basic UDI-DI
B-+ENTIHSV2M054DS0H
EMDN Code
W0105040310 Hsv 2 igm
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025020

Other devices from Gold Standard Diagnostics Frankfurt GmbH

See all devices from Gold Standard Diagnostics Frankfurt GmbH →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No