Left Ventricular Assist System
by Shenzhen Core Medical Technology Co., Ltd.
Ref Corheart 6
Active
CE MDR
Valid until
1 Jul 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697430971PICOPT 16974309711275 | Date31 Jul 2026 | StatusActive |
Certificates
- 4940783CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 29 Jul 2026
- Expires
- 1 Jul 2031
- 4940783TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 29 Jul 2026
- Expires
- 1 Jul 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Left Ventricular Assist System
- Model / Reference
- Corheart 6
- Primary DI / UDI-DI
- 16974309711275
- Basic UDI-DI
- 697430971PICOPT
- EMDN Code
- J01030102 Implantable left monoventricular assistance systems (lvad)
- Device Class
- Class III
- Special Device Type
- Software
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033296
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Properties
Other properties (10)
- 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
- Incorporates Medicinal Product: No