EUDAMED device
MAC 5 A4 Resting ECG Analysis System
EUDAMED device 00195278276070 · GE Medical Systems Information Technologies, Inc.
Key facts
| Primary DI | 00195278276070 |
|---|---|
| Trade name | MAC 5 A4 Resting ECG Analysis System |
| Device name | MAC 5 A4 Resting ECG Analysis System |
| Reference or catalog number | 8855001-001 |
| Model | MAC 5 A4 |
| Manufacturer | GE Medical Systems Information Technologies, Inc. |
| Manufacturer SRN | US-MF-000017529 |
| Risk class | Class IIa |
| EMDN code | Z12050301 |
| EMDN description | ÉLECTROCARDIOGRAPHES À USAGE GÉNÉRAL|ELETTROCARDIOGRAFI PER USO GENERALE|GENERAL PURPOSE ELECTROCARDIOGRAPHS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 16, 2022 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: