RX Herculink Elite™ Peripheral Stent System
by Abbott Medical Ireland EUDAMED
Ref 1011530-12 EMDN P070402020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8717648PBS0002YK | Date17 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 755160 Amended
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 30 Apr 2025
- Expires
- 21 Jul 2027
- Reason
- Other
Specification
- Device Name
- Peripheral Balloon Expanding Stent System, 0.014 in.
- Model / Reference
- 1011530-12
- Primary DI / UDI-DI
- 08717648079115
- Basic UDI-DI
- 8717648PBS0002YK
- EMDN Code
- P070402020102 Non-stainless steel peripheral vascular bare metal stents
- Device Class
- Class IIb
- 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 (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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 08717648079115|8717648PBS0002YK