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Simple GDH-Toxins

by Operon, S.A. EUDAMED

Active European Union

Ref 9.065.020.71.000Model 9.065.XXX.YY.ZZZ

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84295779065Y5 Basic UDI-DIDate13 Mar 2025RegisteredStatusActive

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  • Withdrawn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
9.065.XXX.YY.ZZZ, 9.065.020.71.000
Primary DI / UDI-DI
08429577007892
Basic UDI-DI
84295779065Y5
EMDN Code
W0105090106 Clost. diff. incl gdh and/or toxin a and b - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

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Properties

Show properties
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No