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Inco2 Elegance

by Medexim, spol. s r.o. Slovakia EUDAMED

Ref Inco2 Elegance, FII3000Model CO2 gas injector, INCO2 ELEGANCE EMDN Z12029008

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number858800918202KM Basic UDI-DIDate7 Apr 2022RegisteredStatusActive
European UnionCE/MDR Number858800918202KM Basic UDI-DIDate7 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
CO2 gas injector
Model / Reference
CO2 gas injector, Inco2 Elegance, FII3000
Primary DI / UDI-DI
08588009182429
Basic UDI-DI
858800918202KM, B-08588009182429
Direct Marketing DI
08588009182429
EMDN Code
Z12029008 Gas inflators
Device Class
Class IIa
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000015788

Other devices from Medexim, spol. s r.o.

See all devices from Medexim, spol. s r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function NoEUDAMEDYesEUDAMED
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED d2d99e8b-40ec-4294-9579-99f4362e41bd 61 fields · synced 22 Oct 2026
  • EUDAMED 08588009182429|B-08588009182429 61 fields · synced 8 Oct 2026