Ganshorn Medizin Electronic GmbH
DE-MF-000006566 · Germany · Bad Neustadt
Ganshorn Medizin Electronic GmbH is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: Ergometer, PowerCube+ Series, SanaSedeo 1000, SpiroDef Filter, SpiroScout.
Among these devices, 18 are declared active, 17 with a measuring function.
Devices declared under this manufacturer
- Ganshorn.LFX
- NoseClip
- PowerCube+ Series
- SanaBike 1000
- SanaComfort 1000
- SanaCouch 1000
- SanaSedeo 1000
- SpiroDef Mouthpiece
- SpiroDef Mouthpiece with NoseClip
- SpiroDef SP-250
- SpiroDef SP-260
- SpiroDef ScoutTube
Showing 12 of 24 declared devices.
Catalogue references include 013400563, 019410908, 019420660, 019420661, 019420663, 050000000.
European nomenclature codes declared: Z12159003, Z129003, R049001, Z12150101, Z12069099, Z12159085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GANSHORN MEDIZIN ELECTRONIC GMBH (DE) · FDA 3006419626 |
| Devices in EUDAMED | 24 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 29.2 % |
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. Ganshorn Medizin Electronic GmbH is registered in the United States but was not found in the Canadian register.