Siemens Healthcare Diagnostics Products GmbH
DE-MF-000005039 · Germany · Marburg
Siemens Healthcare Diagnostics Products GmbH is registered in the European database on medical devices as a manufacturer, with 415 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| other | 415 |
|---|
Most frequent device types declared: IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di, IVDR_27_MAR EB_C_PROF_REAG_Thr_S, IVDR_27_MAR EB_C_PROF_REAG_Innovin, IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL, IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL.
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 Diagnostics Products GmbH (DE) · FDA 9610806 |
| Devices in EUDAMED | 415 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1512506-1 | supplemented | 2026-07-28 |
HX 1512506-1 | reissued | 2031-07-28 |