Skip to content

RedRelief Burn Gel 120ml bottle

by Roosin Medical Co., Ltd. FDA registration: China EUDAMED

Ref 403.034003Model Spray type EMDN M04040501

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-26958868781013 Basic UDI-DIDate14 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Spray type, 403.034003
Primary DI / UDI-DI
26958868781013
Basic UDI-DI
B-26958868781013
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIb
Market of Registration
Germany

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 26958868781013|B-26958868781013 61 fields · synced 25 Oct 2026