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HIV1 ELITe MGB® Kit

by ElitechGroup S.p.A. Italy EUDAMED

Ref RTK600ING

EMDN W0105030107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 089014 0012 Date2 Sep 2026IssuedStatusActive expires 2 Sep 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
RTK600ING
Primary DI / UDI-DI
08033891487126
Basic UDI-DI
803389148HIV37D5
Direct Marketing DI
08033891487126
EMDN Code
W0105030107 HIV 1 - na reagents
Device Class
Class D
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 c70d0f88-8609-4368-b14d-67a21f7d3976 61 fields · synced 23 Oct 2026