PowerShock
by Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇ 12 variants
Ref 924967Model CIVL32515
Active
CE MDR
Valid until
19 Apr 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86843131CIVL325154Q 08684313149674 | Date10 Jun 2026 | StatusActive |
Certificates
- 273/MDR Active
Technical documentation EU MDR
- Certifier
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. 0051
- Issued
- 20 Apr 2026
- Expires
- 19 Apr 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Coronary Intravascular Lithotripsy Catheter
- Model / Reference
- CIVL32515, 924967
- Primary DI / UDI-DI
- 08684313149674
- Basic UDI-DI
- 86843131CIVL325154Q
- EMDN Code
- C0104010206, C99
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000045382
Other devices from Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇
See all devices from Shunmei̇ Medi̇kal Ve Tibbi̇ Ci̇hazlar Ti̇caret Anoni̇m Şi̇rketi̇ →
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