FDA Registration
Active
🇨🇳 China
Behind-the-ear hearing aid (model: ZTQ05ZT, ZTQ05ZT Pro)
Reg #: 3019872458
·
FEI: 3019872458
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN EARTECH COMPANY LTD.
- Registration Number
- 3019872458
- FEI Number
- 3019872458
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4-516, Tusincere Science Park, Qingchun Road, Longcheng Street, Longgang
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Eartech Company Ltd.
- Operator Number
- 10092207
- Address
- 4-516, Tusincere Science Park, Qingchun Road, Longcheng Street, Longgang
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- zhongyi deng
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2024-12-12 |
Proprietary Names
Behind-the-ear hearing aid (model: ZTQ05ZT, ZTQ05ZT Pro)
In-the-ear hearing aid(model: Sara 1, Sara 2, Sara 3, Sara 4, Sara 5, Sara 6, Sara 7, Sara 8, Sara 9, Sara 10)
Behind-the-ear hearing aid(model:ZTQ01ZT, ZTQ01ZT Pro, ZTQ02ZT, ZTQ02ZT Pro, ZTQ03ZT ZTQ03ZT Pro, ZTQ04ZT, ZTQ04ZT Pro)
Establishment Types
Manufacture Medical Device