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EBV ELITe Standard

by ElitechGroup S.p.A. Italy EUDAMED

Ref https://www.elitechgroup.com/documentation/

EMDN W0105080908

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803389148EBV20A2 Basic UDI-DIDate3 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
EBV ELITe MGB Kit
Model / Reference
https://www.elitechgroup.com/documentation/
Primary DI / UDI-DI
08033891483661
Basic UDI-DI
803389148EBV20A2
Direct Marketing DI
08033891483661
EMDN Code
W0105080908 Standards and calibrators for all infections/ 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
  • Companion Diagnostics
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 0beab108-8efe-4a45-9d6f-3ec5c55fc29d 61 fields · synced 24 Oct 2026