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

Ref HCTPF 3016Model HOMECATH Hydrophilic Urinary Catheter PVC-Free Tiemann 30 CM 16 CH 40pcs/box

EMDN U01010601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18699415740022 Basic UDI-DIDate15 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 24 Oct 2026

Device Name
HOMECATH Hydrophilic Urinary Catheter PVC-Free Tiemann 30 CM 16 CH
Model / Reference
HOMECATH Hydrophilic Urinary Catheter PVC-Free Tiemann 30 CM 16 CH 40pcs/box, HCTPF 3016
Primary DI / UDI-DI
18699415740022
Basic UDI-DI
B-18699415740022
EMDN Code
U01010601 Tiemann catheters, self-lubricating
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 ea1778ec-5cf9-43ad-a760-b632d0e7893b 61 fields · synced 24 Oct 2026