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Disposable Intermittent Catheter
EUDAMEDClass I (EU MDR)
Ref H01-08MSModel coated, with water sachet PVC catheter
Identity
- Trade Name
- Disposable Intermittent Catheter EUDAMED
- Device Name
- Disposable Intermittent Catheter EUDAMED
- Model / Reference
- coated, with water sachet PVC catheter EUDAMEDH01-08MS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214106960 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
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
Disposable Intermittent Catheter by Chengdu Daxan Innovative Medical Tech.Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 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 288d99e5-ac07-4793-9a9c-5ad7173344b4 61 fields · synced Jun 19, 2026