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HSV2 - ELITe Positive Control

by ElitechGroup S.p.A. Italy EUDAMED

Ref CTR032PLD

EMDN W0105080808

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803389148HSV22EW Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HSV2 ELITe MGB® Kit
Model / Reference
CTR032PLD
Primary DI / UDI-DI
08033891483494
Basic UDI-DI
803389148HSV22EW
Direct Marketing DI
08033891483494
EMDN Code
W0105080808 All infectious diseases controls - nat
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005919

Other devices from ElitechGroup S.p.A.

See all devices from ElitechGroup S.p.A. →

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 08033891483494|803389148HSV22EW 61 fields · synced 24 Oct 2026