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Respiratory Bacterial PLUS ELITe MGB® Kit

by ElitechGroup S.p.A. EUDAMED

Active European Union

Ref RTS190ING

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803389148RBP56E8 Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
RTS190ING
Primary DI / UDI-DI
08033891488017
Basic UDI-DI
803389148RBP56E8
Direct Marketing DI
08033891488017
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005919

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Properties

Show 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