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Sterile Burn Gels

by Roosin Medical Co., Ltd. 4 variants

Ref 403.034006Model Gel type

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-16958868781047 Basic UDI-DI 16958868781047UDI-DIDate22 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Sterile Burn Gels
Model / Reference
Gel type, 403.034006
Primary DI / UDI-DI
16958868781047
Basic UDI-DI
B-16958868781047
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIb
EU 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

  • 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