FDA Registration
Active
🇺🇸 United States
Medley 206, Medley CK, Medley RC, Medley RC800, Medley RK
Reg #: 3011195544
·
FEI: 3011195544
·
Expires 2025
Products
1
Proprietary Names
23
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, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2014-10-08 |
Proprietary Names
Medley 206, Medley CK, Medley RC, Medley RC800, Medley RK
Venti
Lux Auto, Lux Auto Pro, Lux Max, Lux Max SE
Primo R201, Primo R401
Legato 208, Legato 209
Sax 206
Elara
Symphony Pro200, Symphony Pro201, Symphony Pro209, Symphony Pro400, Symphony Pro600, Symphony Pro800
Aria 200, Aria 206, Aria 400, Aria 600, Aria 800
Asana Pro200, Asana Pro400, Asana Pro600, Asana Pro800
Vivo Pro102, Vivo Pro200, Vivo Pro205, Vivo Pro400, Vivo Pro600, Vivo Pro800, Vivo Pro1600
Harp, Harp Pro
SDW Primo U, SDW Rocker
Mila
Allegro
Rocker 200, Rocker 201, Rocker 202, Rocker 203, Rocker 206, Rocker 206D, Rocker 400, Rocker 600, Rocker 602
Primo M201, Primo M401, Primo M801, Primo MP, Primo MP06, Primo MV
Symphony 109, Symphony 210, Symphony 410, Symphony 610, Symphony 810
Primo U200, Primo U400, Primo U600, Primo U800, Primo UP
Chord 600
Forte 200, Forte 400, Forte 800, Forte MV400
Vivo 108, Vivo 109, Vivo 201, Vivo 202, Vivo 206
Asana 220, Asana 420, Asana 620, Asana 820
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device