Manufacturer
Siemens Healthineers
GermanyLegal entities : Siemens Healthineers AG
Markets : Belgium · Germany · Greece · Netherlands · Sweden · Switzerland · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 8 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : Germany 208 · Switzerland 16 · Greece 12 · Netherlands 9 · Sweden 6 · Belgium 3
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Various digital bioimaging management instruments - medical device software | Z11069092 | IIb MDR | EUDAMED record Report an error | |
| Complete cardiography systems | Z12050701 | IIb MDR | EUDAMED record Report an error | |
| Computed tomographs - 128 layers or more but less than 256 layers | Z11030606 | IIb MDR | EUDAMED record Report an error | |
| Closed magnet MRI scanners with magnetic field less than or equal to 2t | Z11050104 | IIa MDR | EUDAMED record Report an error | |
| General medicine diagnosis and monitoring instruments - medical device software | Z12040192 | IIa MDR | EUDAMED record Report an error | |
| Magnetic resonance (mr) systems - medical device software | Z11050192 | IIa MDR | EUDAMED record Report an error | |
| MRI/PET systems | Z11020701 | IIa MDR | EUDAMED record Report an error |
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