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ChitoCare Medical Healing Spray

by Primex ehf Iceland EUDAMED

Ref 84500-8305

EMDN M04041502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-84500-830558 Basic UDI-DIDate26 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 22 Oct 2026

Model / Reference
84500-8305
Primary DI / UDI-DI
D-84500-830558
Basic UDI-DI
B-84500-830558
EMDN Code
M04041502 Dressings in solutions, emulsions, gels, powders with animal components
Device Class
Class III
Market of Registration
Iceland

Manufacturer details

EUDAMED SRN
IS-MF-000003735

From the manufacturer

Manufacturer's product page: Sáragel

Other devices from Primex ehf

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ef2f3cd0-2286-4ec8-adb6-88c3ba33e990 61 fields · synced 22 Oct 2026