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Fix-O-Cath

by Romsons Group Private Limited Plant 6 EUDAMED

Withdrawn No longer placed on the EU market

Ref GS-3179Model I V Cannula Fixator

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8907265H100ZP Basic UDI-DIDate13 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Soflene
Model / Reference
I V Cannula Fixator, GS-3179
Primary DI / UDI-DI
08907265023077, 08907265023053, 08907265023060
Basic UDI-DI
8907265H100ZP
Direct Marketing DI
08907265023077
08907265023053
08907265023060
EMDN Code
M04010202 Polyurethane fixing dressings
Device Class
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000053289
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • Sterile

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No