DK Score Pro Coronary Scoring Balloon Dilatation Catheter
by DK Medical Technology Co., Ltd. 50 variants
Ref CSL-3730
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69722536014CSL5K 06923533810530 | Date25 Feb 2025 | StatusActive |
Certificates
- M.2025.MDR.1062-1 Withdrawn
Technical documentation EU MDR
- Certifier
- UDEM Adriatic d.o.o. 2696
- Issued
- 18 Feb 2025
- Expires
- 17 Feb 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Coronary Scoring Balloon Dilatation Catheter
- Model / Reference
- CSL-3730
- Primary DI / UDI-DI
- 06923533810530
- Basic UDI-DI
- 69722536014CSL5K
- EMDN Code
- C010401020199 Ptca dilatation catheters - other
- Device Class
- Class III
- EU 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
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