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Homecath

by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi 635 variants

Ref HCDA 4016Model HOMECATH Antibacterial Hydrophilic Urinary Catheter Dilacath 40 CM 16 CH 40pcs/box

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18699415700194 Basic UDI-DI 18699415700194UDI-DIDate20 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
HOMECATH Antibacterial Hydrophilic Urinary Catheter Dilacath 40 CM 16 CH
Model / Reference
HOMECATH Antibacterial Hydrophilic Urinary Catheter Dilacath 40 CM 16 CH 40pcs/box, HCDA 4016
Primary DI / UDI-DI
18699415700194
Basic UDI-DI
B-18699415700194
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017811

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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