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Burnshield

by Burnshield (Pty) Ltd 13 variants

Ref L900819

Burnshield (L900819) is a Class IIb device made by Burnshield (Pty) Ltd, registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-06007645005791), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06007645005791 Basic UDI-DI 06007645005791UDI-DIDate14 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Burnshield Essential Burn Kit Medium
Model / reference
L900819
Primary DI / UDI-DI
06007645005791
Basic UDI-DI
B-06007645005791
EMDN code
M0408 Dressings for burns only
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

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

Similar devices in this category

Other devices filed under DRESSINGS FOR BURNS ONLY.

Other devices from Burnshield (Pty) Ltd

See all devices from Burnshield (Pty) Ltd →

Properties

  • Supplied sterile
  • Sterilise before use
  • Contains latex
Other properties (9, all answered No)