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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HKMA 4012Model HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 12 CH 20pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 12 CH EUDAMED
- Model / Reference
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 12 CH 20pcs/box EUDAMEDHKMA 4012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415700316 EUDAMED
- Basic UDI-DI
- B-18699415700316 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Introducing the HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 12 CH, a reliable and efficient device for the management of urinary catheters. With its sleek design and user-friendly interface, this device is designed to make catheterization easier and more comfortable for patients.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18699415700316 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED fd2fe5a9-0349-4e43-8f3f-1a176f70657a 61 fields · synced Oct 7, 2026