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by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi EUDAMED

Active European Union

Ref HCTA-WA 4010Model HOMECATH Antibacterial Hydrophilic Urinary Catheter -Ready To Use Tiemann 40 CM 10 CH 30pcs/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18699415725289 Basic UDI-DIDate24 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  • Withdrawn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 Antibacterial Hydrophilic Urinary Catheter -Ready To Use Tiemann 40 CM 10 CH
Model / Reference
HOMECATH Antibacterial Hydrophilic Urinary Catheter -Ready To Use Tiemann 40 CM 10 CH 30pcs/box, HCTA-WA 4010
Primary DI / UDI-DI
18699415725289
Basic UDI-DI
B-18699415725289
EMDN Code
U01010601 Tiemann catheters, self-lubricating
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017811

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Properties

Show properties
Other properties (11)
  • Sterile: No
  • 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