FDA Registration
Active
🇨🇳 China
ZR-M96, ZR-M97, ZR-M98, ZR-M99, ZR-M92BT, ZR-M93BT, ZR-M94BT, ZR-M95BT, ZR-M96BT, ZR-M97BT, ZR-M98BT, ZR-M99BT, ZR-E16,
Reg #: 3022507139
·
FEI: 3022507139
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Zhongrui Le Listening Medical Equipment Co., Ltd
- Registration Number
- 3022507139
- FEI Number
- 3022507139
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 401, Building 1, No. 106, Zhuangcun Road, Xin er Community, Xinqiao Street, Bao an District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Zhongrui Le Listening Medical Equipment Co., Ltd
- Operator Number
- 10084620
- Address
- 401, Building 1, No. 106, Zhuangcun Road, Xin'er Community, Xinqiao Street, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Hongliang Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
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 | 2025-04-24 |
Proprietary Names
ZR-M96, ZR-M97, ZR-M98, ZR-M99, ZR-M92BT, ZR-M93BT, ZR-M94BT, ZR-M95BT, ZR-M96BT, ZR-M97BT, ZR-M98BT, ZR-M99BT, ZR-E16,
ZR-H712, ZR-H713, ZR-H715, ZR-H716, ZR-H717, ZR-H718, ZR-711A, ZR-H715A, ZR-H716A, ZR-H718A, ZR-G300, ZR-M93, ZR-M95,
Z100, Z101, Z102, Z103, Z105, Z10, Z107, Z108, Z109)
Hearing aids (ZR-HA01, ZR-HA02, ZR-HA03, ZR-H701, ZR-H702, ZR-H703, ZR-H704, ZR-H705, ZR-H706, ZR-H710, ZR-E109,
ZR-100, ZR-101, ZR-102, ZR-103, ZR-105, ZR-106, ZR-107, ZR-108, ZR-109, E100, E101, E102, E103, E105, E106, ZR-G400,
ZR-E32, ZR-E64, ZR-E100, ZR-E101, ZR-E102, ZR-E103, ZR-E105, ZR-E106, ZR-E107, ZR-E108, E107, E108, E109,
ZR- G500, ZR-G600, ZR-G700, ZR-G800, ZR-M902, ZR-M903, ZR-M904, ZR-M905, ZR-M906, ZR-M907, ZR-M908, ZR-M92, ZR-H711,
Establishment Types
Manufacture Medical Device