Homecath
EUDAMEDClass IIa (EU MDR)
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Antibacterial Hydrophilic Urinary Catheter with Water Sachet Pediatric 20 CM 06 CH EUDAMED
- Model / Reference
- HOMECATH Antibacterial Hydrophilic Urinary Catheter with Water Sachet Pediatric 20 CM 06 CH 30pcs/box EUDAMEDHCPA-SN 2006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415703683 EUDAMED
- Basic UDI-DI
- B-18699415703683 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
The HOMECATH Antibacterial Hydrophilic Urinary Catheter with Water Sachet Pediatric 20 CM 06 CH offers a unique combination of sterile design, durable construction, and advanced features. This device is designed for use in pediatric patients, providing reliable and effective treatment of urinary tract infections.
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- 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
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18699415703683 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 778746c5-d463-442f-8587-090118f36ef1 61 fields · synced Oct 7, 2026