FDA Registration
Active
🇨🇳 China
HEYUAN XUANYIN TECHNOLOGY CO., LTD.
Reg #: 3030497233
·
FEI: 3030497233
·
Expires 2026
Products
3
Proprietary Names
19
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- HEYUAN XUANYIN TECHNOLOGY CO., LTD.
- Registration Number
- 3030497233
- FEI Number
- 3030497233
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 305,3rd Floor,4R&DPlant,North of 7th Road,West Xingye Avenue,High-tech Zone,Huaguan Technology(Heyuan)Co.,LTD.
- City
- Heyuan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Heyuan Xuanyin Technology Co., Ltd.
- Operator Number
- 10093178
- Address
- 305,3rd Floor,4R&DPlant,North of 7th Road,West Xingye Avenue,High-tech Zone,Huaguan Technology(Heyuan)Co.,LTD.
- City
- Heyuan
- State
- Guangdong
- Postal Code
- 517000
- Country
- CN
- Correspondent
- Xinhui Luo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2025-04-10 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2025-04-10 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-04-10 |
Proprietary Names
XY-2501D,XY-2502D,XY-2503D,XY-2504D,XY-2505D,XY-2506D,XY-2507D,XY-2508D,
LT-2301D,LT-2302D,LT-2303D,LT-2304D,LT-2305D,LT-2306D,LT-2307D,LT-2308D,LT-2309D,LT-2310D,LT-2311D,LT-2312D,LT-2313D,
LT-2314D,LT-2315D,LT-2316D,LT-2317D,LT-2318D,LT-2319D,LT-2320D,
XY-P01D,XY-P02D,XY-P03D,XY-P04D,XY-P05D,XY-P06D,XY-P07D,XY-P08D,XY-P09D,XY-P10D,
XY-P12D,XY-P13D,XY-P14D,XY-P15D,XY-P16D,XY-P17D,XY-P18D,XY-P19D
HEARING AIDS:
XY-2501,XY-2502,XY-2503,XY-2504,XY-2505,XY-2506,XY-2507,XY-2508,
LT-2311,LT-2312,LT-2313,LT-2314,LT-2315,LT-2316,LT-2317,LT-2318,LT-2319,LT-2320,
LT-2301,LT-2302,LT-2303,LT-2304,LT-2305,LT-2306,LT-2307,LT-2308,LT-2309,LT-2310,
XY-P01,XY-P02,XY-P03,XY-P04,XY-P05,XY-P06,XY-P07,XY-P08,XY-P09,
Hearing Aid:
XY-P11,XY-P12,XY-P13,XY-P14,XY-P15,XY-P16,XY-P17,XY-P18,XY-P19
XY-P01BTD,XY-P02BTD,XY-P03BTD,XY-P04BTD,XY-P05BTD,XY-P06BTD,XY-P07BTD,XY-P08BTD,
Hearing Aid with Wireless Technology:
LT-2301BTD,LT-2302DBT,LT-2303BTD,LT-2304BTD,LT-2305BTD,LT-2306BTD,LT-2307BTD,
LT-2315BTD,LT-2316BTD,LT-2317BTD,LT-2318BTD,LT-2319BTD,LT-2320BTD,
XY-P09BTD,XY-P11BTD,XY-P12BTD,XY-P13BTD,XY-P14BTD,XY-P15BTD,XY-P16BTD,XY-P17BTD,XY-P18BTD,XY-P19BTD
XY-2501BTD,XY-2502BTD,XY-2503BTD,XY-2504BTD,XY-2505BTD,XY-2506BTD,XY-2507BTD,XY-2508BTD,
LT-2308BTD,LT-2309BTD,LT-2310BTD,LT-2311BTD,LT-2312BTD,LT-2313BTD,LT-2314BTD,
Establishment Types
Manufacture Medical Device