Ampere™
by Abbott Medical EUDAMED
Active
Ref H700491-CQM
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5414734ABC00226B | Date24 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Ampere System
- Model / Reference
- H700491-CQM
- Primary DI / UDI-DI
- 05415067046772
- Basic UDI-DI
- 5414734ABC00226B
- Direct Marketing DI
- 05415067046772
- EMDN Code
- Z12059011 Cardiac ablation equipment
- Device Class
- Class IIb
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000033655
- Authorised representative
- Abbott Medical BE-AR-000008744
Other devices from Abbott Medical
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- 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
- Incorporates Medicinal Product: No