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Alethia Chlamydia

by Meridian Bioscience Inc. United States EUDAMED

Ref 480450 EMDN W0105010117

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number008407331ALETHIACLC009RT Basic UDI-DIDate15 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
480450
Primary DI / UDI-DI
00840733102202
Basic UDI-DI
008407331ALETHIACLC009RT
Direct Marketing DI
00840733102202
EMDN Code
W0105010117 Chlamydia trachomatis detection by na reagents
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000044096
Authorised representative
Meridian Bioscience Europe S.r.l. IT-AR-000010460

Other devices from Meridian Bioscience, Inc.

See all devices from Meridian Bioscience, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00840733102202|008407331ALETHIACLC009RT 61 fields · synced 25 Oct 2026