FDA Registration
Active
🇺🇸 United States
BRAIN NAVI LLC
Reg #: 3042048690
·
FEI: 3042048690
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- BRAIN NAVI LLC
- Registration Number
- 3042048690
- FEI Number
- 3042048690
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 919 N Market St Ste 950
- City
- Wilmington
- State
- DE
- ZIP
- 19801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242575
Owner / Operator
- Firm Name
- Brain Navi LLC
- Operator Number
- 10094347
- Address
- 919 N. Market St. STE 950
- City
- Wilmington
- State
- DE
- Postal Code
- 19801
- Country
- US
- Correspondent
- Chieh-Hsiao Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-11-26 |
Proprietary Names
NaoTrac S
Establishment Types
Complaint File Establishment per 21 CFR 820.198