EUDAMED device
EK12
EUDAMED device 00195278457547 · GE Medical Systems Information Technologies, Inc.
Key facts
| Primary DI | 00195278457547 |
|---|---|
| Trade name | EK12 |
| Device name | EK12 |
| Reference or catalog number | 2104498-003 |
| Model | Starting from V2 |
| Manufacturer | GE Medical Systems Information Technologies, Inc. |
| Manufacturer SRN | US-MF-000017529 |
| Risk class | Class IIa |
| EMDN code | Z12050392 |
| EMDN description | ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 9, 2024 |
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: