Ampere™
by Abbott Medical EUDAMED
Active
Ref H700491
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05415067004918 | Date28 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Ampere Generator and Accessories
- Model / Reference
- H700491
- Primary DI / UDI-DI
- 05415067004918
- Basic UDI-DI
- B-05415067004918
- 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