Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
by Abbott Medical EUDAMED
Active
Ref 2213250-09
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 809145 | Date20 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Certificates
- MDR 809145 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 20 Aug 2026
- Expires
- 14 Aug 2030
- Reason
- Add device or group
Specification
- Model / Reference
- 2213250-09
- Primary DI / UDI-DI
- 08717648365034
- Basic UDI-DI
- 8717648DRS0001YM
- EMDN Code
- P0704020299 Peripheral vascular stents - other
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000003851
- Authorised representative
- Abbott Vascular International BE-AR-000002043
Other devices from Abbott Medical
Properties
Other properties (10)
- 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