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HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 16 CH
EUDAMEDClass IIa (EU MDR)
Ref HKMA 4016Model HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 16 CH 20pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Device Name
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 16 CH EUDAMED
- Model / Reference
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 16 CH 20pcs/box EUDAMEDHKMA 4016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415700330 EUDAMED
- Basic UDI-DI
- B-18699415700330 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
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
HOMECATH Antibacterial Hydrophilic Urinary Catheter Kit Male 40 CM 16 CH by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class IIa — MDD…
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Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
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- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
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- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
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-18699415700330 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 4260c372-8cf9-4b69-90e8-091ce98e7e34 61 fields · synced Oct 8, 2026