FDA Registration
Active
🇩🇪 Germany
ExacTrac Dynamic
Reg #: 8043933
·
FEI: 3002619595
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BRAINLAB AG
- Registration Number
- 8043933
- FEI Number
- 3002619595
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Olof-Palme-Strasse 9
- City
- Munich Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K203173
Owner / Operator
- Firm Name
- Brainlab AG
- Operator Number
- 9004547
- Address
- Olof-Palme-Strasse 9
- City
- Munich
- State
- Bavaria
- Postal Code
- 81829
- Country
- DE
US Agent
- Business Name
- BRAINLAB, INC.
- Contact Name
- Paul Neil
- Address
- 5 Westbrook Corporate Ctr Ste 1000
- City
- WESTCHESTER
- State
- IL
- ZIP
- 60154
- Country
- US
- [email protected]
- Phone
- 708 4091343
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2020-11-13 |
Proprietary Names
ExacTrac Dynamic
Establishment Types
Manufacture Medical Device