Disposable Intermittent Catheter
EUDAMEDClass I (EU MDR)
Identity
- Trade Name
- Disposable Intermittent Catheter EUDAMED
- Device Name
- Disposable Intermittent Catheter EUDAMED
- Model / Reference
- coated, with water sachet PVC catheter EUDAMEDH01-10PMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214106908 EUDAMED
- Basic UDI-DI
- 697197678DXACE0105VL EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
The Disposable Intermittent Catheter, manufactured by Chengdu Daxan Innovative Medical Tech.Co.,Ltd (H01-10PMS), is a standard disposable catheter with a coated design and water sachet PVC construction. This device meets the regulatory requirements of its applicable legislation ID (-197) and has undergone comprehensive testing to ensure sterility and safety.
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
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697197678DXACE0105VL | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu Daxan Innovative Medical Tech.Co., Ltd
- EUDAMED SRN
- CN-MF-000033805
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 95d17e93-0a73-46cc-91d8-3f3899dab955 61 fields · synced Oct 7, 2026