- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 2, 2025
805901671TOTEM-UGA3IT-MF-000023616No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.4 warnings recorded — scroll inside the panel to see all entries.
CW010CW135CW014CW259Primary placement in Italy; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Apr 24, 2025 | Still on market |
| Austria | Apr 24, 2025 | Still on market |
| Belgium | Apr 24, 2025 | Still on market |
| Germany | Apr 24, 2025 | Still on market |
| Spain | Apr 24, 2025 | Still on market |
| France | Apr 24, 2025 | Still on market |
| Ireland | Apr 24, 2025 | Still on market |
| Iceland | Apr 24, 2025 | Still on market |
| Malta | Apr 24, 2025 | Still on market |
| Netherlands | Apr 24, 2025 | Still on market |
| Portugal | Apr 24, 2025 | Still on market |
| XI | Apr 24, 2025 | Still on market |
(01)08059016711006
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)Z12062701PERINEAL STIMULATORSZ12062499BIOFEEDBACK INSTRUMENTS - OTHER