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Discs for antimicrobial susceptibility testing Gemifloxacin, GEM, 5mcg

by Tody Laboratories Med SRL EUDAMED

Active European Union

Ref C39SD1098

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number594067440SUSCEPT.DISCSZK Basic UDI-DIDate30 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Susceptibility Discs
Model / Reference
C39SD1098
Primary DI / UDI-DI
05940674401329
Basic UDI-DI
594067440SUSCEPT.DISCSZK
EMDN Code
W0104080502 Impregnated disks, multi-disks & tablets
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
RO-MF-000037201

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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