Brainlab SE
DE-MF-000006183 · Germany · Munich
Brainlab SE is registered in the European database on medical devices as a manufacturer, with 406 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 291 |
|---|---|
| Class IIb | 111 |
| Class I | 4 |
Most frequent device types declared: 41860-42, 51839-45, Instrument Adapter, 51839, Instrument Tracking Array.
Among these devices, 17 are declared sterile, 69 reusable, 83 active, 33 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 | BRAINLAB SE (DE) · FDA 8043933 |
| Devices in EUDAMED | 406 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 037489 0098 | issued | 2031-02-09 |
G70 037489 0072 | amended | 2028-03-13 |
G70 037489 0071 | amended | 2028-03-15 |
G12 037489 0070 | amended | 2028-03-30 |
G11 037489 0060 | amended | 2028-06-26 |
G10 037489 0059 | reissued | 2030-09-13 |