Senzime AB
SE-MF-000016903 · Sweden · Uppsala
Senzime AB is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: RMI-51110, RMI-53040, SEN 2002, SEN 2010, SEN 2012.
Among these devices, 2 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- ExSpiron Adult PadSets
- ExSpiron Pediatric PadSets
- TetraGraph Monitor
- TetraGraph Philips Interface
- TetraGraph Pole Clamp Kit
- TetraGraph Xcom
- TetraHub
- TetraSens Electrode
- TetraSens Pediatric
- TetraSensitive
Showing 12 of 14 declared devices.
Catalogue references include RMI-51110, SEN 2007, SEN 2010, SEN 2012, SEN 2013, SEN 2015.
European nomenclature codes declared: Z12062899, Z1203019003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SENZIME AB (SE) · FDA 3016490024 |
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 100.0 % |
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: United States only. Senzime AB is registered in the United States but was not found in the Canadian register.