Cometa S.r.l.
IT-MF-000012630 · Italy · Bareggio
Cometa S.r.l. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: CGE, InsoleX, MWPB, Myowise Software, Wave Plus Wireless EMG.
Among these devices, 12 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Aktos-t
- EMG AND MOTION TOOLS
- Footswitch
- InsoleX BT
- InsoleX RF
- Myon Aktos
- Myowise
- Myowise Software
- Picoblue
- Wave Plus Wireless EMG
- WaveTrack
- WaveX
Showing 12 of 16 declared devices.
Catalogue references include AT180, EMGMT, GLD-EL, MW, Picoblue, WP180R1.
European nomenclature codes declared: Z12100701, Z12062699, Z12062602, Z12100401, Z12100482, Z12062682.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. Cometa S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1343909 1 | supplemented | 2028-03-27 |