Dr. Fenyves und Gut Deutschland GmbH
DE-MF-000005715 · Germany · Rangendingen
Dr. Fenyves und Gut Deutschland GmbH is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 82 |
|---|
Among these devices, 27 are declared active, 27 with a measuring function.
Devices declared under this manufacturer
- Doppel-LEG-Sensor
- EKG Elektrodenkabel 3-polig
- Fingersensor SpO2 Erwachsene mit Lemostecker
- Fingersensor SpO2 Erwachsene, mit Lemostecker
- Legsensor
- MiniScreen Plus Patient Recorder
- PC-Software OR5
- PC-Software Sleep Xpert
- Samoa lite Patient Recorder
- SleepDoc Porti 10 PSG Patient Recorder
- SleepDoc Porti 7-P Patient Recorder
- Sonata Neuro Module 10-20
Showing 12 of 82 declared devices.
Catalogue references include 920100, 920102, 925306, 925314, 926450, 927027.
European nomenclature codes declared: Z129012, Z12040180, C900301, Z12100501, Z12100580, R020199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 82 |
| 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 | 82 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DR. FENYVES UND GUT DEUTSCHLAND GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2025-05-23 |
Licence types: System (4).
Licensed under: SONATA POLYSOMNOGRAPHY SYSTEM, SAMOA, VITALNIGHT PG, VITALNIGHT PSG.
North American profile: Canada only. Dr. Fenyves und Gut Deutschland GmbH holds a Canadian licence but was not found in the U.S. register.