FDA Registration
Active
🇹🇭 Thailand
Rechargeable OTC Hearing Aids (ION)
Reg #: 3038280943
·
FEI: 3038280943
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DONPON PRECISION (THAILAND) CO., LTD
- Registration Number
- 3038280943
- FEI Number
- 3038280943
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 60/2 Moo.3 Hangsung sub district Nong Yai district
- City
- Chonburi province
- Country
- TH
Owner / Operator
- Firm Name
- Donpon Precision (Thailand) Co., LTD
- Operator Number
- 10093386
- Address
- 60/2 Moo.3 Hangsung sub district Nong Yai district
- City
- Chonburi province
- State
- TH-NOTA
- Postal Code
- 20190
- Country
- TH
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
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 | 2025-05-08 |
Proprietary Names
Rechargeable OTC Hearing Aids (ION)
Rechargeable OTC Hearing Aids (ATOM ONE, ATOM 2, ATOM PRO2, FA915, FA916, FA816)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)