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GoldCath

by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref 2010Model Hydrophılıc Urınary Catheter Sheath GKF-CH 10-20 CM, Hydrophilic Urinary Kit GKT-CH 10-20 CM, Hydrophilic Urinary Catheter Ring GYU-CH 10-20 CM, Hydrophilic Urinary Catheter Dilatation GDL-CH 10-20 CM, Urinary Nelaton Catheter GN-CH 10-20 CM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680110401854 Basic UDI-DIDate23 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  • Withdrawn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
Hydrophılıc Urınary Catheter Sheath
Hydrophilic Urinary Kit
Hydrophilic Urinary Catheter Ring
Hydrophilic Urinary Catheter Dilatation
Urinary Nelaton Catheter
Model / Reference
Hydrophılıc Urınary Catheter Sheath GKF-CH 10-20 CM, 2010, Hydrophilic Urinary Kit GKT-CH 10-20 CM, Hydrophilic Urinary Catheter Ring GYU-CH 10-20 CM, Hydrophilic Urinary Catheter Dilatation GDL-CH 10-20 CM, Urinary Nelaton Catheter GN-CH 10-20 CM
Primary DI / UDI-DI
08680110401854, 08680110400833, 08680110401175, 08680110402530, 08680110403537
Basic UDI-DI
B-08680110401854, B-08680110400833, B-08680110401175, B-08680110402530, B-08680110403537
EMDN Code
U01010501, U01010502
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038388

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

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