St. Jude Medical Infinity™
by Abbott Medical EUDAMED
Active
Ref 6393
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5415067DBS0001BQ | Date13 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Slovenia
- Spain
- Sweden
Certificates
- MDR 744775 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 4 Aug 2026
- Expires
- 19 Dec 2026
- Reason
- Other
Specification
- Device Name
- Deep Brain Stimulation
- Model / Reference
- 6393
- Primary DI / UDI-DI
- 05415067027887
- Basic UDI-DI
- 5415067DBS0001BQ
- EMDN Code
- J020180 Cerebral implantable neurostimulators - accessories
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000028918
- Authorised representative
- Abbott Medical BE-AR-000008744
Other devices from Abbott Medical
Properties
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