X.ACT™ Carotid Stent System
by Abbott Medical Ireland EUDAMED
Ref XRX02008S EMDN P070402020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8717648CAR0002QW | Date26 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 768949 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 27 May 2026
- Expires
- 12 Jul 2028
- Reason
- Other
Specification
- Device Name
- Carotid Stent System, X.ACT
- Model / Reference
- XRX02008S
- Primary DI / UDI-DI
- 08717648007507
- Basic UDI-DI
- 8717648CAR0002QW
- EMDN Code
- P070402020102 Non-stainless steel peripheral vascular bare metal stents
- 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 & raw data
Show properties, registry sources and raw records
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: 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 08717648007507|8717648CAR0002QW