Lumenis (Germany) GmbH
DE-MF-000007655 · Germany · Dreieich-Dreieichenhain
Lumenis (Germany) GmbH is registered in the European database on medical devices as a manufacturer, with 87 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 73 |
|---|---|
| Class IIa | 14 |
Most frequent device types declared: NA.
Among these devices, 4 are declared sterile, 1 reusable, 72 active.
Devices declared under this manufacturer
- AcuPulse Incisional Handpiece 125mm
- AcuPulse Upgrade Kit 40AES-F to 40AES-R
- AcuPulse™
- Alpha CPG
- DeepFX MicroScanner
- Focused Incisional HP 0.2mm and 1.0
- TrueSpot™ 2.0mm Handpiece
Showing 12 of 87 declared devices.
Catalogue references include AC-00013550GR, AC-2005212BeGR, GA-1130000BeGR, GA-1140000BeGR, KT-1006456BeGR, SA-1146410BeGR , SPSA-1146410BeGR.
European nomenclature codes declared: V9099, Z12011080, Z12011019, L2499, Z12011005, Z12011016.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 87 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 87 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Lumenis (Germany) GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1417800015 | supplemented | 2027-05-19 |