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by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi EUDAMED

Active European Union

Ref HCID 4012Model HOMECATH Hydrophilic Instillation Urinary Catheter Dilacath 40 CM 12 CH 40pcs/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699415700944 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
HOMECATH Hydrophilic Instillation Urinary Catheter Dilacath 40 CM 12 CH
Model / Reference
HOMECATH Hydrophilic Instillation Urinary Catheter Dilacath 40 CM 12 CH 40pcs/box, HCID 4012
Primary DI / UDI-DI
08699415700944
Basic UDI-DI
B-08699415700944
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

Show 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