SOMNOmedics AG
DE-MF-000006921 · Germany · Randersacker
SOMNOmedics AG is registered in the European database on medical devices as a manufacturer, with 298 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 298 |
|---|
Most frequent device types declared: ABPMpro software, Cable, ECG sensor, Effort belt, Effort sensor.
Among these devices, 261 are declared active, 213 with a measuring function.
Devices declared under this manufacturer
- ABPMpro Software
- Cable for Sleep Adagio Headbox
- ECG-Sensor
- EDA Sensor
- Effort + 2PLM Combi Sensor
- Effort belt
- Extension cable for sensors - PLM input
- Microphone for high Sampling Rate (Snore)
- Nasal/Oral flow sensor thermistor adult for Sleep Adagio
- OtwoFellow (Size L)
- Pneumatic Effort Belt - Size S
- Replacement Effort sensor
Showing 12 of 298 declared devices.
Catalogue references include CIR003, SAS095B, SEN073, SEN224, SEW131, SW100.
European nomenclature codes declared: Z1203020280, Z12100580, Z12100501, Z12100380, Z1203020299, Z1203020202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SOMNOMEDICS AG (DE) · FDA 3006258337 |
| Devices in EUDAMED | 298 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 298 |
|---|---|
| Found in the U.S. device database | 72 |
| Share | 24.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SOMNOMEDICS AG |
North American profile: Both markets. SOMNOmedics AG is registered in both the United States and Canada.