Disentis AB
SE-MF-000050466 · Sweden · Hisings Backa
Disentis AB is registered in the European database on medical devices as a manufacturer, with 109 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 109 |
|---|
Most frequent device types declared: WR0002, WR0004, WR0003, 007 Waye Readers Sun Demi Brown Black / Sun lens 10, WR0011.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 109 |
| Country of registration | Sweden |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.