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GoldCath

by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 18 variants

Ref 4016Model Hydrophilic Urinary Kit GKT-CH 16-40 CM, Hydrophilic Urinary Catheter Dilatation GDL-CH 16-40 CM, Hydrophılıc Urınary Catheter Sheath GKF-CH 16-40 CM, Urinary Nelaton Catheter GN-CH 16-40 CM, Hydrophilic Urinary Catheter Ring GYU-CH 16-40 CM

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680110400703 Basic UDI-DI Date23 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Hydrophilic Urinary Kit
Hydrophilic Urinary Catheter Dilatation
Hydrophılıc Urınary Catheter Sheath
Urinary Nelaton Catheter
Hydrophilic Urinary Catheter Ring
Model / Reference
Hydrophilic Urinary Kit GKT-CH 16-40 CM, 4016, Hydrophilic Urinary Catheter Dilatation GDL-CH 16-40 CM, Hydrophılıc Urınary Catheter Sheath GKF-CH 16-40 CM, Urinary Nelaton Catheter GN-CH 16-40 CM, Hydrophilic Urinary Catheter Ring GYU-CH 16-40 CM
Primary DI / UDI-DI
08680110400703, 08680110402400, 08680110401724, 08680110403360, 08680110401045
Basic UDI-DI
B-08680110400703, B-08680110402400, B-08680110401724, B-08680110403360, B-08680110401045
EMDN Code
U01010501, U01010502
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038388

Related devices

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

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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