Skip to content

Purelon

by Teki̇met Özel Sağlik Turi̇zmi̇ Gida İnşaat Temi̇zli̇k Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref TKMT-01Model Sodium Hyaluronate OVD

EMDN Q02030399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683916590036 Basic UDI-DIDate28 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
Sodium Hyaluronate OVD purelon 1.4% 1.5ml 27 G
Model / Reference
Sodium Hyaluronate OVD, TKMT-01
Primary DI / UDI-DI
08683916590036
Basic UDI-DI
B-08683916590036
EMDN Code
Q02030399 Ophthalmology, viscoelastic fluids - other
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000042393

Other devices from Teki̇met Özel Sağlik Turi̇zmi̇ Gida İnşaat Temi̇zli̇k Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

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 26540864-1a7d-4ab0-a86a-2f1646e2bc3a 61 fields · synced 24 Oct 2026