Solaris Vascular Stent Graft
by Scitech Produtos Médicos SA Brazil EUDAMED
Ref 129447Model SOLARIS VASCULAR STENT GRAFT EMDN P070401020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number79082497SOLARISCB | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-015 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Feb 2025
- Expires
- 7 Feb 2030
- 2025-MDR/TD-015 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Feb 2025
- Expires
- 7 Feb 2030
Specification
- Device Name
- Vascular Stent Graft
- Model / Reference
- SOLARIS VASCULAR STENT GRAFT, 129447
- Primary DI / UDI-DI
- 07908249721591
- Basic UDI-DI
- 79082497SOLARISCB
- EMDN Code
- P070401020103 Ptfe vascular endoprostheses, straight - peripheral
- Device Class
- Class IIb
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- BR-MF-000018627
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Scitech Produtos Médicos SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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
Sources (1)
- EUDAMED 3a28b92d-b196-4d67-9d19-29883080966c