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Purelon

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

Ref TKMT-01Model TP-18150, TP-10085, SODIUM HYALORANATE OVD

EMDN Q02030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683916590272 Basic UDI-DIDate29 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
Sodium Hyaluronate OVD purelon 1.6% 1.5ml 27 G
Model / Reference
TKMT-01, TP-18150, TP-10085, SODIUM HYALORANATE OVD
Primary DI / UDI-DI
08683916590272, 08683916590128, 08683916590135, 08683916590180, 08683916590197, 08683916590067, 08683916590159, 08683916590050, 08683916590029, 08683916590043
Basic UDI-DI
B-08683916590272, B-08683916590128, B-08683916590135, B-08683916590180, B-08683916590197, B-08683916590067, B-08683916590159, B-08683916590050, B-08683916590029, B-08683916590043
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
  • Sterile YesEUDAMEDNoEUDAMED
  • Reprocessed NoEUDAMEDYesEUDAMED
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (10)

  • EUDAMED 0fa43537-1a9d-40bc-9270-164975a39c97 61 fields · synced 24 Oct 2026
  • EUDAMED 08683916590128|B-08683916590128 61 fields · synced 11 Jul 2026
  • EUDAMED 08683916590135|B-08683916590135 61 fields · synced 11 Jul 2026
  • EUDAMED 08683916590180|B-08683916590180 61 fields · synced 11 Jul 2026
  • EUDAMED 08683916590197|B-08683916590197 61 fields · synced 12 Jul 2026
  • EUDAMED 08683916590067|B-08683916590067 61 fields · synced 12 Jul 2026
  • EUDAMED 08683916590159|B-08683916590159 61 fields · synced 12 Jul 2026
  • EUDAMED 08683916590050|B-08683916590050 61 fields · synced 14 Jul 2026
  • EUDAMED 08683916590029|B-08683916590029 61 fields · synced 18 Jul 2026
  • EUDAMED 08683916590043|B-08683916590043 61 fields · synced 17 Sep 2026