FDA Registration
Active
🇺🇸 United States
Maxum
Reg #: 3012118649
·
FEI: 3012118649
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ototronix, LLC (Minnesota)
- Registration Number
- 3012118649
- FEI Number
- 3012118649
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5000 Township Pkwy
- City
- White Bear Township
- State
- MN
- ZIP
- 55110
- Country
- US
Regulatory Submissions
- PMA Number
- P010023
Owner / Operator
- Firm Name
- Ototronix, LLC
- Operator Number
- 10031730
- Address
- 5000 Township Parkway
- City
- Saint Paul
- State
- MN
- Postal Code
- 55110
- Country
- US
- Correspondent
- Brant Newman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Hearing, Active, Middle Ear, Partially Implanted | MPV | Class 3 | Unknown | No | 2010-03-03 |
Proprietary Names
Maxum
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device