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ETEST® Amikacin (AK)

by bioMérieux SA France EUDAMED

Ref 542872 EMDN W0104080501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number357302BUDI000760TX Basic UDI-DIDate21 May 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  • Withdrawn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 24 Oct 2026

Model / Reference
542872
Primary DI / UDI-DI
03573026622091
Basic UDI-DI
357302BUDI000760TX
Unit of Use DI
03573026622381
EMDN Code
W0104080501 Mic systems - dilution methods (incl. e-test)
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004436

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

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 03573026622091|357302BUDI000760TX 61 fields · synced 24 Oct 2026