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Kelo-Cote Scar Treatment

by Advanced Bio-Technologies EUDAMED

Active European Union

Model Kelo-Cote Gel

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5036631008301SN Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Kelo-Cote Scar Gel
Model / Reference
Kelo-Cote Gel
Primary DI / UDI-DI
D-5036631008301SN
Basic UDI-DI
B-5036631008301SN
EMDN Code
M04010203 Fixation silicone dressings
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000037322
Authorised representative
Alliance Pharma (Ireland) Ltd IE-AR-000022483

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Properties

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