PTA Balloon Dilatation Catheters
by Beijing Demax Medical Technology Co., Ltd. EUDAMED
Active
Ref DMC02010-14070Model DMC03020-35040
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69437182VelutFS | Date21 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- PTA Balloon Dilatation Catheters
- Model / Reference
- DMC03020-35040, DMC02010-14070
- Primary DI / UDI-DI
- 06943718274223
- Basic UDI-DI
- 69437182VelutFS
- EMDN Code
- C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000005844
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Beijing Demax Medical Technology Co., Ltd.
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Properties
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