Siemens Healthineers AG
DE-MF-000038456 · Germany · Forchheim
Siemens Healthineers AG is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 22 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: MDR_02_IIa_FOR AG S3_ACDV_Magnetom, MDR_03_II b_FOR S3_CT_Scanner, MDR_DnA_IIb_SHS_AG_SAMD_SPACE, MDR_02_IIa_FOR AG S3_ACDV_mMR, MDR_01_IIa_FOR_ACDV_FACE.
Among these devices, 29 are declared active, 1 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 Healthineers AG (DE) · FDA 3004977335 |
| Devices in EUDAMED | 30 |
| Country of registration | Germany |