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GoldCath

by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref 2018Model Urinary Nelaton Catheter GN-CH 18-20 CM, Hydrophılıc Urınary Catheter Sheath GKF-CH 18-20 CM, Hydrophilic Urinary Catheter Dilatation GDL-CH 18-20 CM, Hydrophilic Urinary Catheter Ring GYU-CH 18-20 CM, Hydrophilic Urinary Kit GKT-CH 18-20 CM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680110403490 Basic UDI-DIDate24 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Urinary Nelaton Catheter
Hydrophılıc Urınary Catheter Sheath
Hydrophilic Urinary Catheter Dilatation
Hydrophilic Urinary Catheter Ring
Hydrophilic Urinary Kit
Model / Reference
Urinary Nelaton Catheter GN-CH 18-20 CM, 2018, Hydrophılıc Urınary Catheter Sheath GKF-CH 18-20 CM, Hydrophilic Urinary Catheter Dilatation GDL-CH 18-20 CM, Hydrophilic Urinary Catheter Ring GYU-CH 18-20 CM, Hydrophilic Urinary Kit GKT-CH 18-20 CM
Primary DI / UDI-DI
08680110403490, 08680110401816, 08680110402493, 08680110401137, 08680110400796
Basic UDI-DI
B-08680110403490, B-08680110401816, B-08680110402493, B-08680110401137, B-08680110400796
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