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Sterile Burn Gel

by Roosin Medical Co., Ltd. United States EUDAMED

Ref 403.001003Model Dressing type EMDN M04040501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-16958868781092 Basic UDI-DIDate4 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sterile Burn Gel
Model / Reference
Dressing type, 403.001003
Primary DI / UDI-DI
16958868781092
Basic UDI-DI
B-16958868781092
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIb
Market of Registration
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 16958868781092|B-16958868781092 61 fields · synced 25 Oct 2026