EUDAMED device
ECG app
EUDAMED device 00190198909534 · Apple Inc.
Key facts
| Primary DI | 00190198909534 |
|---|---|
| Device name | ECG app |
| Reference or catalog number | ECG app 1.X |
| Model | 1.X |
| Manufacturer | Apple Inc. |
| Manufacturer SRN | US-MF-000013709 |
| Risk class | Class IIa |
| EMDN code | Z12050382 |
| EMDN description | ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 22, 2025 |
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: