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Crystasoothe

by Aurena Laboratories AB EUDAMED

Withdrawn Not intended for the EU market

Ref 301358Model REF 2004

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620131862-04 Date10 Jun 2026IssuedStatusWithdrawn Not intended for the EU market expires 27 Oct 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Burn Gel
Model / Reference
REF 2004, 301358
Primary DI / UDI-DI
07332343300572
Basic UDI-DI
7332343200037H
Direct Marketing DI
07332343300572
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
SE-MF-000002890

Other devices from Aurena Laboratories AB

See all devices from Aurena Laboratories AB →

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No