Ghunter
by Sinomed NeuroVita Technology Inc. 9 variants
Ref ISR 3-30Model ISR 3-20
Active
CE MDR
Valid until
1 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6974741385001CN 06974741380650 | Date3 Mar 2026 | StatusActive |
Certificates
- 2291466CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 18 Feb 2026
- Expires
- 1 Feb 2031
- 2291466TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 18 Feb 2026
- Expires
- 1 Feb 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ghunter Revascularization Device
- Model / Reference
- ISR 3-20, ISR 3-30
- Primary DI / UDI-DI
- 06974741380650
- Basic UDI-DI
- 6974741385001CN
- EMDN Code
- C019010 Intravascular recanalisation systems
- Device Class
- Class III
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000041241
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Sinomed NeuroVita Technology Inc.
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