Skip to content

Sterile Burn Gels

by Roosin Medical Co., Ltd. United States EUDAMED

Ref 403.034008Model Dressing type

EMDN M04040501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-16958868781061 Basic UDI-DIDate22 Mar 2023RegisteredStatusActive

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

Device Name
Sterile Burn Gels
Model / Reference
Dressing type, 403.034008
Primary DI / UDI-DI
16958868781061
Basic UDI-DI
B-16958868781061
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIb
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000021163
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Roosin Medical Co., Ltd.

See all devices from Roosin 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 0bae2bcb-c05f-4a69-bb9b-2618e559f66c 61 fields · synced 25 Oct 2026