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Foam Dressing

by Zhende Medical Co., Ltd. United States EUDAMED

Ref FDA1010-GFLX

EMDN M04040601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942273343955 Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
FDA1010-GFLX
Primary DI / UDI-DI
06942273343955
Basic UDI-DI
B-06942273343955
EMDN Code
M04040601 Polyurethane dressings, non-combined
Device Class
Class IIb
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000009961
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Zhende Medical Co., Ltd.

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06942273343955|B-06942273343955 61 fields · synced 25 Oct 2026