A.R.C. Laser GmbH
DE-MF-000009383 · Germany · Nürnberg
A.R.C. Laser GmbH is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 17 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: LS03500, LS09002, LL28060s, LS09011, LS09010.
Among these devices, 2 are declared sterile, 19 active.
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 | A.R.C. LASER GMBH (DE) · FDA 3006617841 |
| Devices in EUDAMED | 19 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 002848 0008 | issued | 2028-07-24 |