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: LL28060s, LS03500, LS09002, LS09010, LS09011.
Among these devices, 2 are declared sterile, 19 active.
Devices declared under this manufacturer
- CITO 532
- COBRA
- Donut Fiber, 400 µm
- Donut Fiber, 600 μm
- FOX IV
- Q-Las
Showing 12 of 19 declared devices.
Catalogue references include LL28060s, LL28061s, LS03500-AABB, LS03500-AWAB, LS03500-BWAA, LS03500-GWAA.
European nomenclature codes declared: Z12011017, Z12011016, Z12011085.
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 |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | A.R.C. LASER AG |
North American profile: Both markets. A.R.C. Laser GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 002848 0008 | issued | 2028-07-24 |