Disposable Intermittent Catheter
by Chengdu Daxan Innovative Medical Tech.Co., Ltd China EUDAMED
Ref H11-T-18FLModel balltip,coated,ready-to-use, TPU catheter
EMDN U010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697197678DXACE0119VX | Date5 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- balltip, coated, ready-to-use, TPU catheter, H11-T-18FL
- Primary DI / UDI-DI
- 06942214123189
- Basic UDI-DI
- 697197678DXACE0119VX
- EMDN Code
- U010199 Urethral prostatic and bladder catheters, not self-retained - other
- Device Class
- Class I
- Market of Registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000033805
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED df025392-1c7d-4c37-88c3-abc99faf8405