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GoldCath

by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref 2008Model Urinary Nelaton Catheter GN-CH 08-20 CM, Hydrophilic Urinary Catheter Ring GYU-CH 08-20 CM, Hydrophilic Urinary Kit GKT-CH 08-20 CM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680110403544 Basic UDI-DIDate24 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
Urinary Nelaton Catheter
Hydrophilic Urinary Catheter Ring
Hydrophilic Urinary Kit
Model / Reference
Urinary Nelaton Catheter GN-CH 08-20 CM, 2008, Hydrophilic Urinary Catheter Ring GYU-CH 08-20 CM, Hydrophilic Urinary Kit GKT-CH 08-20 CM
Primary DI / UDI-DI
08680110403544, 08680110401182, 08680110400840
Basic UDI-DI
B-08680110403544, B-08680110401182, B-08680110400840
EMDN Code
U01010502, U01010501
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038388

Other devices from Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Sterile

Other properties (10)

  • 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