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_01_IIa_FOR_ACDV_FACE, MDR_01_IIb_FOR_ACDV_SENTICOR, MDR_02_IIa_FOR AG S3_ACDV_Magnetom, MDR_02_IIa_FOR AG S3_ACDV_SaMD, MDR_02_IIa_FOR AG S3_ACDV_mMR.
Among these devices, 29 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- BIOGRAPH One
- LungMaps
- MAGNETOM Altea
- MAGNETOM Flow.Elite
- MAGNETOM Flow.Neo
- MAGNETOM Free.XL
- MAGNETOM Lumina
- MAGNETOM Sola
- MAGNETOM Vida
- MAGNETOM Vida Fit
- SENTICOR Pure
- Syngo Carbon Space
Showing 12 of 30 declared devices.
Catalogue references include 11108440, 11344916, 11410371, 11516152, 11569839, 11689172.
European nomenclature codes declared: Z11050104, Z11050105, Z11069092, Z11030606, Z11020701, Z12040192.
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 |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 46.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIEMENS HEALTHINEERS AG |
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| Class 3 devices | 2 |
| First licensed | 2013-08-01 |
Licence types: System (11), Single Device (1).
Licensed under: SYNGO DYNAMICS, MAGNETOM VIDA, MAGNETOM SOLA, MAGNETOM ALTEA, MAGNETOM LUMINA, MAGNETOM VIDA FIT.
North American profile: Both markets. Siemens Healthineers AG is registered in both the United States and Canada.