Sentec AG
CH-MF-000008058 · Switzerland · Therwil
Sentec AG is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 46 |
|---|
Among these devices, 4 are declared active, 1 with a measuring function.
Authorised representative in the Union: Sentec GmbH.
Devices declared under this manufacturer
- Calibration Gas
- Digital Sensor Adapter Cable 150 cm
- Ear Clip
- Isolation Transformer
- LuMon™ Connector 2.0
- LuMon™ Monitor
- Membrane Changer
- Membrane Changer Insert
- Multi-Site Attachment Ring
- Patient Application Kit for mature/intact skin
- Patient Application Kit for sensitive/fragile skin
- Sensor Adapter Cable (Extra Long)
Showing 12 of 46 declared devices.
Catalogue references include 103149, 1ST120-100, EC-MI, GAS-0812, MAR-SF, MARe-MI.
European nomenclature codes declared: Z1203020405, Z120499, Z1203020405,Z1203020485.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SENTEC AG (CH) · FDA 3004149774 |
| Devices in EUDAMED | 46 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 46 |
|---|---|
| Found in the U.S. device database | 41 |
| Share | 89.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SENTEC AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2008-10-07 |
Licence types: System (1).
Licensed under: SENTEC DIGITAL MONITORING SYSTEM.
North American profile: Both markets. Sentec AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 005260 0005 | supplemented | 2031-08-08 |
G10 005260 0004 | issued | 2026-08-08 |