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Burnshield

by Burnshield (Pty) Ltd South Africa EUDAMED

Ref L550012

EMDN M0408

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06007645000505 Basic UDI-DIDate14 May 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 24 Oct 2026

Device Name
Burnshield Easy Care Burn Kit Blue
Model / Reference
L550012
Primary DI / UDI-DI
06007645000505
Basic UDI-DI
B-06007645000505
EMDN Code
M0408 Dressings for burns only
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
ZA-MF-000018376
Authorised representative
Burnshield Europe B.V. NL-AR-000014621

Other devices from Burnshield (Pty) Ltd

See all devices from Burnshield (Pty) Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (9)
  • Implantable: No
  • Reusable: 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 06007645000505|B-06007645000505 61 fields · synced 24 Oct 2026