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: CT-Scanner_IIb_ERLN H 127, MDR_01_IIb_FOR_ACDV_CIARTIC Move, MDR_01_IIb_FOR_ACDV_Sensis Vibe, MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx), MDR_02_IIa_ERLN H 127_ACDV_Magnetom.
Among these devices, 164 are declared active, 27 with a measuring function.
Devices declared under this manufacturer
- ARTIS icono biplane
- CIARTIC Move
- MAGNETOM Vida
- MOBILETT Elara Max
- SOMATOM Definition Flash
- Sensis Vibe Combo
- YSIO X.pree VA20-SW-Update
- syngo Application Software
- syngo Virtual Cockpit
- syngo.CT Colonography
- syngo.CT Dental
- syngo.CT Dual Energy
Showing 12 of 166 declared devices.
Catalogue references include 11060815, 11108130, 11546418, 11546460, 11582891, 11665703.
European nomenclature codes declared: Z11030682, Z11069092, Z11050104, Z11030102, Z11050105, Z11030606.
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 |
Device-level evidence
| Devices with a numeric GTIN | 166 |
|---|---|
| Found in the U.S. device database | 117 |
| Share | 70.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIEMENS HEALTHCARE GMBH |
What it holds in Canada
| Licences on record | 139 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 80 |
| Class 3 devices | 59 |
| First licensed | 1999-09-08 |
Licence types: System (62), Single Device (48), Device Family (27), Device Group Family (1).
Licensed under: SIREMOBIL C-ARMS, SYNGO MULTIMODALITY WORKPLACE, AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMS, SYNGO IMAGING, MOBILETT XP MOBILE X-RAY SYSTEMS, MAGNETOM AVANTO.
North American profile: Both markets. Siemens Healthcare GmbH is registered in both the United States and Canada.