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Silicone Foam Dressing

by Huizhou Foryou Medical Devices Co., Ltd. China EUDAMED

Ref FKSILBS2323

EMDN M04040602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69406101SF00018N Basic UDI-DIDate8 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Silicone Foam Dressing
Model / Reference
FKSILBS2323
Primary DI / UDI-DI
26940610113470
Basic UDI-DI
69406101SF00018N
Unit of Use DI
16940610113848
EMDN Code
M04040602 Polyurethane dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000007344
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 26940610113470|69406101SF00018N 61 fields · synced 24 Oct 2026