Clinical Laserthermia Systems AB
SE-MF-000016898 · Sweden · Lund
Clinical Laserthermia Systems AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: 3001-01, 4013-14.
Among these devices, 11 are declared sterile.
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 | Registered with FDA |
|---|---|
| Matched entry | CLINICAL LASERTHERMIA SYSTEMS AB (SE) · FDA 3012452798 |
| Devices in EUDAMED | 11 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 081830 0011 | issued | 2029-11-26 |