Byteflies NV
BE-MF-000014680 · Belgium · Berchem
Byteflies NV is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: Byteflies Kit Model 2, CardioCare@Home Pro, ECG Adhesive, EEG Adhesive, Vital Signs Pro.
Among these devices, 1 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Byteflies Kit Model 2
- CardioCare@Home Pro
- ECG Adhesive Multi Lead Linear
- ECG Adhesive Single Lead
- ECG Adhesive Single Lead Extra
- EEG Adhesive
- Vital Signs Pro
Catalogue references include BF13000248, Byteflies Kit Model 2, CardioCare@Home Pro, ECG Adhesive Multi Lead Linear, ECG Adhesive Single Lead Extra, EEG Adhesive.
European nomenclature codes declared: C020501, N01010299, V92, Z12050392, Z12030299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Byteflies NV was not found in either the U.S. or the Canadian register.