Luxamed GmbH & Co. KG
DE-MF-000006437 · Germany · Blaubeuren
Luxamed GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 201 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 201 |
|---|
Most frequent device types declared: wall diagnostic center.
Among these devices, 162 are declared active.
Devices declared under this manufacturer
- Diagnostic penlight LED, black
- Diagnostic penlight LED, green
- Diagnostic penlight LED, grey
- Diagnostic penlight LED, yellow
- Diagnostic penlight with standard bulb, red
- Diagnostic penlight with standard bulb, white, KIDS
- LED examination lamp, with 5-feet stand, white, short
- LuxaScope Oculus
- Otoscope smartled luxamed, myrtille
- Otoscope smartled luxamed, pediatrique
- Otoskop&Ophthalmoskop Diagnostik Set 2.5V, KIDS
- Otoskop&Ophthalmoskop Diagnostik Set 2.5V, weiß/weißblau
Showing 12 of 201 declared devices.
Catalogue references include A1.516.514, A5.101.144, C1.716.914, D1.212.412, E1.344.012, E1.442.012.
European nomenclature codes declared: Z129004, Z12021003, Z12040108, Z12149006, Z12149080, C9005.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LUXAMED GMBH & CO. KG (DE) · FDA 3013394987 |
| Devices in EUDAMED | 201 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 201 |
|---|---|
| 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: United States only. Luxamed GmbH & Co. KG is registered in the United States but was not found in the Canadian register.