Sensatronic GmbH
DE-MF-000004927 · Germany · Wismar
Sensatronic GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: AR-275PHA, EC-30-PM, GP-75-12P, GP-75-9P, PR-275PHA.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- EC-15-PM
- EC-30-PM
- GP-75-12P
- GP-75-9P
- SD-75P
Catalogue references include 011-01401, 011-01402, 011-01405, 013-00080, 013-00081, 013-00082.
European nomenclature codes declared: V03010299, V030180, V03010201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SENSATRONIC GMBH (DE) · FDA 3010370454 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SENSATRONIC GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2017-07-11 |
Licence types: Device Family (4).
Licensed under: TEMPERATURE PROBE LP (SKIN APPLICATION), TEMPERATURE PROBE LP (RECTAL/ESOPHAGEAL APPLIC, GENERAL PURPOSE SINGLE-USE TEMPERATURE PROBE, SKIN SINGLE-USE TEMPERATURE PROBE.
North American profile: Both markets. Sensatronic GmbH is registered in both the United States and Canada.