Silk Vista Baby Intracranial self-expandable stent
by Balt extrusion SAS 18 variants
Ref SILK_V_3,25X25
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-03700481338056 03700481338056 | 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- Withdrawn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 12 May 2018
- Belgium since 12 May 2018
- Bulgaria since 12 May 2018
- Croatia since 12 May 2018
- Cyprus since 12 May 2018
- Czechia since 12 May 2018
- Denmark since 12 May 2018
- Estonia since 12 May 2018
- Finland since 12 May 2018
- France since 12 May 2018
- Germany since 12 May 2018
- Greece since 12 May 2018
- Hungary since 12 May 2018
- Iceland since 12 May 2018
- Ireland since 12 May 2018
- Italy since 12 May 2018
- Latvia since 12 May 2018
- Liechtenstein since 12 May 2018
- Lithuania since 12 May 2018
- Luxembourg since 12 May 2018
- Malta since 12 May 2018
- Netherlands since 12 May 2018
- Northern Ireland since 12 May 2018
- Norway since 12 May 2018
- Poland since 12 May 2018
- Portugal since 12 May 2018
- Romania since 12 May 2018
- Slovakia since 12 May 2018
- Slovenia since 12 May 2018
- Spain since 12 May 2018
- Sweden since 12 May 2018
- Türkiye since 12 May 2018
Specification
- Device Name
- Silk Vista Baby Intracranial self-expandable stent
- Model / Reference
- SILK_V_3, 25X25
- Primary DI / UDI-DI
- 03700481338056
- Basic UDI-DI
- B-03700481338056
- 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 (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