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SmoothCath™
EUDAMEDClass I (EU MDR)
Ref SMC30-0820Model Hydrophilic Urinary Catheter with Water Socket
by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- SmoothCath™ EUDAMED
- Device Name
- Sterile Single Use Hydrophilic Urinary Catheter EUDAMED
- Model / Reference
- Hydrophilic Urinary Catheter with Water Socket EUDAMEDSMC30-0820 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680495073882 EUDAMED
- Basic UDI-DI
- 868049507UK3U EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
SmoothCath™ by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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
- 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
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 868049507UK3U | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000037637
Sources (1)
- EUDAMED 5af0d8ab-b742-4fa4-b738-ee1bddccedcb 61 fields · synced Oct 7, 2026