FDA Registration
Active
🇺🇸 United States
Roger Focus II
Reg #: 3008848788
·
FEI: 3008848788
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Sonova USA Inc.
- Registration Number
- 3008848788
- FEI Number
- 3008848788
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 444 Commerce Street
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
Owner / Operator
- Firm Name
- Sonova AG
- Operator Number
- 9028479
- Address
- Laubisruetistrasse 28
- City
- Staefa
- State
- Zurich
- Postal Code
- 8712
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Assistive Listening | LZI | Class 2 | Ear, Nose, Throat | No | 2020-06-05 |
Proprietary Names
Roger Focus II
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device