Electrolytic eCLIPs Bifurcation System
by Evasc Medical Systems Corp. EUDAMED
Active
Ref SYSS-0039
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000300703 | Date16 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000246351 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 10 Jul 2025
- Expires
- 24 May 2027
- Reason
- Change approved
- 1000300703 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 16 Mar 2026
- Expires
- 24 May 2027
- Reason
- Add device or group
Specification
- Device Name
- Electrolytic eCLIPs Bifurcation System
- Model / Reference
- SYSS-0039
- Primary DI / UDI-DI
- +G062SYSS00390
- Basic UDI-DI
- ++G062eCLIPsA2
- EMDN Code
- Z12109099 Various neurology and neurosurgery instruments - other
- Device Class
- Class III
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CA-MF-000010543
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Evasc Medical Systems Corp.
Properties
Other properties (11)
- 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