DK Score Pro Coronary Scoring Balloon Dilatation Catheter
by DK Medical Technology Co., Ltd. China EUDAMED
Ref CSL-2010
EMDN C010401020199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69722536014CSL5K | Date25 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- M.2025.MDR.1062-1 Withdrawn
Technical documentation EU MDR
- Notified body
- UDEM Adriatic d.o.o. 2696
- Issued
- 18 Feb 2025
- Expires
- 17 Feb 2028
- Reason
- Other
Specification
- Device Name
- Coronary Scoring Balloon Dilatation Catheter
- Model / Reference
- CSL-2010
- Primary DI / UDI-DI
- 06923533800784
- Basic UDI-DI
- 69722536014CSL5K
- EMDN Code
- C010401020199 Ptca dilatation catheters - other
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011218
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from DK Medical Technology Co., Ltd.
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 aa317162-e4a4-46a7-ace7-8a9b78d88e77