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: 4056481AdFlatMarker2T, 41860-42, 41860-46, 51839, 51839-45.
Among these devices, 17 are declared sterile, 69 reusable, 83 active, 33 with a measuring function.
Devices declared under this manufacturer
- C-ARM ADAPTER FOR GE OEC 3D LEFT
- Cranial 4PI Headrest Inlay Standard 2Pcs
- Disposable Loop-X Detector Drape (1 Pc)
- Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw
- Drill Bit Cranial 2.1/2.5
- Drill Guide Depth Control ( 0-60 mm)
- EM Instrument Tracker
- PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L
- SRS 4PI CT TABLE OVERLAY
- Suction STD (CH8) Starlink
- ULTRASOUND NAVIGATION ADAPTER (BK X18L5S)
- V-Inset GE Headholder Kit
Showing 12 of 406 declared devices.
Catalogue references include 19154-07, 22183-13, 43430, 51839-01, 55790-05A, 55825.
European nomenclature codes declared: Z12011480, Z11019080, Z11069092, S010499, Z12011485, Z12011492.
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 |
Device-level evidence
| Devices with a numeric GTIN | 406 |
|---|---|
| Found in the U.S. device database | 390 |
| Share | 96.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BRAINLAB SE |
What it holds in Canada
| Licences on record | 38 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 24 |
| Class 3 devices | 14 |
| First licensed | 2006-10-31 |
Licence types: Device Family (13), System (12), Single Device (11), Device Group Family (1).
Licensed under: IMAGE GUIDED SURGERY SPINE/TRAUMA SOFTWARE, IMAGE GUIDED SURGERY CRANIAL/ENT SOFTWARE, BRAINLAB POINTER, BRAINLAB DRILL BIT, SPINE INSTRUMENT SET, VARIOGUIDE.
North American profile: Both markets. Brainlab SE is registered in both the United States and Canada.
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 |