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by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi Türkiye EUDAMED

Ref HCIM 4008Model HOMECATH Hydrophilic Instillation Urinary Catheter Male 40 CM 08 CH 40pcs/box

EMDN U1301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699415700784 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HOMECATH Hydrophilic Instillation Urinary Catheter Male 40 CM 08 CH
Model / Reference
HOMECATH Hydrophilic Instillation Urinary Catheter Male 40 CM 08 CH 40pcs/box, HCIM 4008
Primary DI / UDI-DI
08699415700784
Basic UDI-DI
B-08699415700784
EMDN Code
U1301 Solutions for bladder washing and instillation
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017811

Other devices from İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8805a3ab-a91b-4bd0-addc-2ac125038590 61 fields · synced 22 Oct 2026