FDA Registration
Active
🇺🇸 United States
SOTERIX MEDICAL,INC.
Reg #: 3012182497
·
FEI: 3012182497
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SOTERIX MEDICAL,INC.
- Registration Number
- 3012182497
- FEI Number
- 3012182497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1480 US Highway 9 North, 204
- City
- Woodbridge
- State
- NJ
- ZIP
- 07095
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192823
Owner / Operator
- Firm Name
- Soterix Medical,Inc.
- Operator Number
- 10054978
- Address
- 1480 US Highway 9 North, 204
- City
- Woodbridge
- State
- NJ
- Postal Code
- 07095
- Country
- US
- Correspondent
- Abhishek Datta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2023-12-01 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2023-12-01 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2024-06-13 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2024-06-13 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-06-13 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2024-06-13 |
| Device, Iontophoresis, Other Uses | EGJ | Class 2 | Physical Medicine | No | 2017-05-19 |
Proprietary Names
MEGA-TMS
MEGA-IOM
IontoDC
Establishment Types
Manufacture Medical Device