FDA Registration
Active
🇨🇳 China
Flysound Hearing Aid,H1,H2,H3,H4,H5,H6,H7,H8,H9,H10,H11,H12,H13,H14,H15,H16,H17,H18,H19,H20,H21,H22,H23,H24,,H25,H26
Reg #: 3034733579
·
FEI: 3034733579
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SHENZHEN FLYSOUNDS MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3034733579
- FEI Number
- 3034733579
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18th Floor, Building A, Jindingshengkechuang Park, No. 356 Dahe Road, Qinghu Community, Longhua Street, Longhua District,
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Flysounds Medical Technology Co., Ltd.
- Operator Number
- 10092282
- Address
- 18th Floor, Building A, Jindingshengkechuang Park, No. 356 Dahe Road, Qinghu Community, Longhua Street, Longhua District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
US Agent
- Business Name
- Registrar Corp.
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2024-12-19 |
Proprietary Names
Flysound Hearing Aid,H1,H2,H3,H4,H5,H6,H7,H8,H9,H10,H11,H12,H13,H14,H15,H16,H17,H18,H19,H20,H21,H22,H23,H24,,H25,H26
FS-B31,FS-B32,FS-B33,FS-B34,FS-B35,FS-B36,FS-B37,FS-B38,FS-B39,FS-B40FS-B1,FS-B2,FS-B3
FS-R26,FS-R27,FS-R28,FS-R29FS-R30,FS-R31,FS-R32,FS-R33,FS-R34,FS-R35,FS-R36
R05,R06,R07,R08,R09,R10,R11,R12,R13,R14,R15,R16,R17,R18,R19,R20,R21,R22,R23,R24,R25R26,R27,R28,R29,R30
FS-B4,FS-B5,FS-B6,FS-B7,FS-B8,FS-B9,FS-B10,FS-B11,FS-B12,FS-B13,FS-B14,FS-B15,FS-B16,FS-B17,FS-B18,FS-B19
FS-B15,FS-B16FS-B17,FS-B18,FS-B19,FS-B20,FS-B21,FS-B22,FS-B23,FS-B24,FS-B25,FS-B26,FS-B27,FS-B28,FS-B29,FS-B30
R31,R32,R33,R34,R35,R36,R37,R38,R39,R40B01,B02,B03,B04,B05,B06,B07,B08,B09,B10,B11,B12,B13,B14
H27,H28,H29,H30,H31,H32,H33,H34,H35,H36,H37,H38,H39,H40,FS-R1,FS-R2,FS-R3,FS-R4,FS-R5,FS-R6,FS-R7,FS-R8,FS-R9,FS-R10
B15,B16,B17,B18,B19,B20,B21,B22,B23,B24,B25,B26,B27,B28,B29,B30,B31,B32,B33,B34,B35,B36,B37,B38,B39,B40
FS-B31,FS-B32,FS-B33,FS-B34,FS-B35,FS-B36,FS-B37,FS-B38,FS-B39,FS-B40R01,R02,R03R04
FS-R11,FS-R12,FS-R13,FS-R14,FS-R15,FS-R16,FS-R17,FS-R18,FS-R19,FS-R20,FS-R21,FS-R22,FS-R23,FS-R24,FS-R25
FS-B20,FS-B21,FS-B22,FS-B23,FS-B24,FS-B25,FS-B26,FS-B27,FS-B28,FS-B29,FS-B30
FS-R37,FS-R38,FS-R39,FS-R40FS-B1,FS-B2FS-B3,FS-B4,FS-B5,FS-B6,FS-B7,FS-B8,FS-B9,FS-B10,FS-B11,FS-B12,FS-B13,FS-B14
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device