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Kelo-Cote Scar Treatment

by Advanced Bio-Technologies 11 variants

Model Kelo-Cote Gel

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-5036631008332SZ Basic UDI-DI D-5036631008332SZUDI-DIDate12 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Kelo-Cote Scar Gel
Model / Reference
Kelo-Cote Gel
Primary DI / UDI-DI
D-5036631008332SZ
Basic UDI-DI
B-5036631008332SZ
EMDN Code
M04010203 Fixation silicone dressings
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

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

Other devices from Advanced Bio-Technologies, Inc.

See all devices from Advanced Bio-Technologies, Inc. →

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