Sterile Urinary Catheter for single use
by Jiangsu Suyun Medical Materials Co., Ltd. EUDAMED
Active
Model Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69332982010V5 | Date22 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile Urinary Catheter for single use
- Model / Reference
- Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml)
- Primary DI / UDI-DI
- 06933298297743
- Basic UDI-DI
- 69332982010V5
- EMDN Code
- U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
- Device Class
- Class IIa
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000021132
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (11)
- Implantable: No
- Reusable: 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