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Burngel

by Akla Ab Sweden EUDAMED

Ref 94298

EMDN M04040501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07311410942983E6 Basic UDI-DIDate27 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
Burngel
Model / Reference
94298
Primary DI / UDI-DI
D-07311410942983E6
Basic UDI-DI
B-07311410942983E6
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000004567

Other devices from Akla Ab

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • 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 8e5d96ac-f0e2-4f19-a66d-07fe6dcd3991 61 fields · synced 24 Oct 2026