FDA Registration
Active
🇺🇸 United States
SDW BW20, SDW FORTE MA, SDW FORTE MA201, SDW ULITE 2000
Reg #: 3011195544
·
FEI: 3011195544
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- IMHEAR CORPORATION
- Registration Number
- 3011195544
- FEI Number
- 3011195544
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 600 N Commons Dr Ste 107
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
Owner / Operator
- Firm Name
- IMHEAR CORPORATION
- Operator Number
- 10047588
- Address
- 600 N Commons Dr., Suite 107
- City
- Aurora
- State
- IL
- Postal Code
- 60504
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2019-06-07 |
Proprietary Names
SDW BW20, SDW FORTE MA, SDW FORTE MA201, SDW ULITE 2000
LUX MAX AIR, LUX TV AIR
POCO RA801, POCO UA
PRIMO MA, PRIMO RA1600
FORTE MA201, FORTE MA801
ULITE 2000
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device