Emboshield NAV6™ Embolic Protection System
by Abbott Medical EUDAMED
Active
Ref 22442-19
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8717648EPS0001YC | Date26 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Not drawn on the map: Northern Ireland.
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Lithuania
- Luxembourg
- Netherlands
- Northern Ireland
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- MDR 762887 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 27 May 2026
- Expires
- 27 Aug 2028
- Reason
- Other
Specification
- Device Name
- Embolic Protection System, NAV6
- Model / Reference
- 22442-19
- Primary DI / UDI-DI
- 08717648137761
- Basic UDI-DI
- 8717648EPS0001YC
- EMDN Code
- C01050202 PTA embolic protection catheters and systems
- 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 (11)
- Implantable: No
- 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