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Primacath

by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref 4010Model Hydrophilic Urinary Catheter Ring PYU-CH 10-40 CM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680110403810 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  • Withdrawn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
Hydrophilic Urinary Catheter Ring
Model / Reference
Hydrophilic Urinary Catheter Ring PYU-CH 10-40 CM, 4010
Primary DI / UDI-DI
08680110403810
Basic UDI-DI
B-08680110403810
EMDN Code
U01010501 Nelaton catheters, self-lubricating
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