SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH
DE-MF-000048702 · Germany · Frechen
SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: Bipolare Surface EMG electrode 21mm, orthoS8 (2-Channel), orthoS8 (4-Channel), orthoS8 (6-Channel), orthoS8.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- orthoS8
- orthoTRODE2
Catalogue references include 121, 3701-2, 3701-4, 3701-6, 3701-8.
European nomenclature codes declared: Z12100701, Z12100485.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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. SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH was not found in either the U.S. or the Canadian register.