FDA Registration
Active
🇺🇸 United States
Go Prime OTC Hearing Aids
Reg #: 3015246392
·
FEI: 3015246392
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- hearX USA
- Registration Number
- 3015246392
- FEI Number
- 3015246392
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2140 South DuPont Highway, Camden, Kent County
- City
- Camden
- State
- DE
- ZIP
- 19934
- Country
- US
Owner / Operator
- Firm Name
- hearX Group
- Operator Number
- 10057906
- Address
- Ground Floor, Building 2, Ashlea Gardens Office Park,, 180 Garsfontein Road, Ashlea Gardens
- City
- Pretoria
- State
- Gauteng
- Postal Code
- 0081
- Country
- ZA
- Correspondent
- Seline van der Wat
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-10-19 |
Proprietary Names
Go Prime OTC Hearing Aids
Establishment Types
Repack or Relabel Medical Device