Geratherm Respiratory GmbH
DE-MF-000006818 · Germany · Bad Kissingen
Geratherm Respiratory GmbH is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Among these devices, 12 are declared active, 10 with a measuring function.
Devices declared under this manufacturer
- Add-on CO Diffusion
- Ambistik
- Ambistik CPET
- Ambistik PFT
- Blue Cherry
- Bodystik
- Diffustik
- Ergostik
- Ergostik Blueflow
- PFTstik
- Safestik
- Spiraflow & Softclip Set
Showing 12 of 16 declared devices.
Catalogue references include 259149, 340968, 361333-BF, 534860, 618751, 634247.
European nomenclature codes declared: Z12159080, Z12150101, Z12159003, Z12150185, Z12159099, Z12159007.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| 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 | 16 |
|---|---|
| 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. Geratherm Respiratory GmbH was not found in either the U.S. or the Canadian register.