FDA Registration
Active
🇲🇾 Malaysia
Tinnitus Sound Generator Module
Reg #: 3011927597
·
FEI: 3011927597
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GN ReSound (Malaysia) Sdn Bhd.
- Registration Number
- 3011927597
- FEI Number
- 3011927597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 5, Jalan i-Park 1/1, Kawasan Perindustrian i-Park
- City
- Kulai Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K181586
Owner / Operator
- Firm Name
- GN Hearing A/S
- Operator Number
- 2182204
- Address
- Lautrupbjerg 7
- City
- Ballerup
- State
- Hovedstaden
- Postal Code
- 2750
- Country
- DK
- Correspondent
- Pernille Bartel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2019-02-27 |
Proprietary Names
Tinnitus Sound Generator Module
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)