EUDAMED device
Ambulatory Electrocardiograph
EUDAMED device 00817980020191 · Vasomedical Inc.
Key facts
| Primary DI | 00817980020191 |
|---|---|
| Trade name | Ambulatory Electrocardiograph |
| Device name | Vasomedical-Biox™ 1303 Ultra Compact 3 Channel ECG Holter Recorder |
| Reference or catalog number | 04.13.03.0001 |
| Model | Model 1303 |
| Manufacturer | Vasomedical Inc. |
| Manufacturer SRN | US-MF-000030121 |
| Risk class | Class IIa |
| EMDN code | Z12050403 |
| EMDN description | ECG HOLTER RECORDERS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Apr 17, 2023 |
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)