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Sign in to claim this brandBRAINSCOPE
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 7648 Standish Place, Rockville, MD, 20855
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3008660657
- DUNS Number
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Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BrainScope One | Ahead 500 CUBC1 | FDA UDI | Class II | Active |
| Baseline Headset | 99-1803-202 | FDA UDI | Class II | Active |
| Ahead 300 | 99-1403-002 | FDA UDI | Class II | Active |
| BrainScope One | 99-1403-002 | FDA UDI | Class II | Active |
| Electrode Headset | 99-1403-202 | FDA UDI | Class II | Active |
| BrainScope One International Charging Kit | 99-1403-028 | FDA UDI | Class II | Active |
| Ahead 300 International Charging Kit | 99-1403-028 | FDA UDI | Class II | Active |
| Ahead Electrode Headset | 99-1403-202 | FDA UDI | Class II | Active |
| BrainScope One | Ahead 500 | FDA UDI | Class II | Active |
| BrainScope Ahead 100 | DEN140025 | FDA 510(k) | Class II | Active |
| Zoom-100dc | K082886 | FDA 510(k) | Class II | Active |
| Ahead 300 | K161068 | FDA 510(k) | Class II | Active |
| BrainScope TBI (Model: Ahead 400) | K183241 | FDA 510(k) | Class II | Active |
| BrainScope TBI | K190815 | FDA 510(k) | Class II | Active |
| Modified BrainScope One | K181785 | FDA 510(k) | Class II | Active |
| Brainscope Ahead 200 | K143643 | FDA 510(k) | Class II | Active |
| BrainScope One | K181179 | FDA 510(k) | Class II | Active |
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