Siemens Healthcare GmbH
DE-MF-000006122 · Germany · Erlangen
Siemens Healthcare GmbH is registered in the European database on medical devices as a manufacturer, with 166 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 94 |
|---|---|
| Class IIa | 72 |
Most frequent device types declared: syngo.CT PP_IIa_App_ERLN H 127, MDR_02_IIa_ERLN H 127_ACDV_Magnetom, MDR_05_FOR_SYNGO_SaMD_IIb, CT-Scanner_IIb_ERLN H 127, MDR_01_IIb_FOR_ACDV_Artis zee/Q (VD12).
Among these devices, 164 are declared active, 27 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Siemens Healthcare GmbH (DE) · FDA 3011194542 |
| Devices in EUDAMED | 166 |
| Country of registration | Germany |