Silk Vista Intracranial self-expandable stent
by Balt extrusion SAS 26 variants
Ref SILK_V_4,75X20
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-03700481330654 03700481330654 | Date5 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
EU market availability
Made available in 32 countries, as listed in EUDAMED:
- Austria since 24 Jun 2020
- Belgium since 24 Jun 2020
- Bulgaria since 24 Jun 2020
- Croatia since 24 Jun 2020
- Cyprus since 24 Jun 2020
- Czechia since 24 Jun 2020
- Denmark since 24 Jun 2020
- Estonia since 24 Jun 2020
- Finland since 24 Jun 2020
- France since 24 Jun 2020
- Germany since 24 Jun 2020
- Greece since 24 Jun 2020
- Hungary since 24 Jun 2020
- Iceland since 24 Jun 2020
- Ireland since 24 Jun 2020
- Italy since 24 Jun 2020
- Latvia since 24 Jun 2020
- Liechtenstein since 24 Jun 2020
- Lithuania since 24 Jun 2020
- Luxembourg since 24 Jun 2020
- Malta since 24 Jun 2020
- Netherlands since 24 Jun 2020
- Northern Ireland since 24 Jun 2020
- Norway since 24 Jun 2020
- Poland since 24 Jun 2020
- Portugal since 24 Jun 2020
- Romania since 24 Jun 2020
- Slovakia since 24 Jun 2020
- Slovenia since 24 Jun 2020
- Spain since 24 Jun 2020
- Sweden since 24 Jun 2020
- Türkiye since 24 Jun 2020
Specification
- Device Name
- Silk Vista Intracranial self-expandable stent
- Model / Reference
- SILK_V_4, 75X20
- Primary DI / UDI-DI
- 03700481330654
- Basic UDI-DI
- B-03700481330654
- EMDN Code
- P070402020102 Non-stainless steel peripheral vascular bare metal stents
- Device Class
- Class III
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000007563
From the manufacturer
Manufacturer's product page: LEO+ Self-Expandable Braided Stent
Other devices from Balt extrusion SAS
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