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Burngel

by Akla Ab Sweden EUDAMED

Ref 94399

EMDN M04040501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07311410943997EQ 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
94399
Primary DI / UDI-DI
D-07311410943997EQ
Basic UDI-DI
B-07311410943997EQ
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

See all devices from Akla Ab →

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 f17c8e1d-5a17-45ed-93aa-f646ef24f8b3 61 fields · synced 24 Oct 2026