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Alginate Dressing

by Winner Medical Co., Ltd. United States EUDAMED

Ref FAD1140EModel Alginate dressing (Type I)

EMDN M04040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694109403532EL Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

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
Alginate Dressing
Model / Reference
Alginate dressing (Type I), FAD1140E
Primary DI / UDI-DI
16942327045696
Basic UDI-DI
694109403532EL
EMDN Code
M04040201 Alginate dressings, non-combined
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000005692
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Winner Medical Co., Ltd.

See all devices from Winner Medical Co., Ltd. →

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 16942327045696|694109403532EL 61 fields · synced 24 Oct 2026