Balloon dilatation catheter
by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. China EUDAMED
Ref 090080090HCModel 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC EMDN C010402020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697174170BDC000188 | Date31 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Balloon dilatation catheter
- Model / Reference
- 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC, 090080090HC
- Primary DI / UDI-DI
- 06971741707456
- Basic UDI-DI
- 697174170BDC000188
- Direct Marketing DI
- 06971741707456
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000037464
- 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 (11)
- Implantable: No
- Reusable: No
- Contains Latex: 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 06971741707456|697174170BDC000188