FDA Registration
Active
🇨🇳 China
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Reg #: 3011350813
·
FEI: 3011350813
·
Expires 2026
Products
4
Proprietary Names
58
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Registration Number
- 3011350813
- FEI Number
- 3011350813
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Hangzhou Acosound Technology Co., Ltd.
- Operator Number
- 10053274
- Address
- Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Lingling Wang
US Agent
- Business Name
- GVM MEDICAL LLC
- Contact Name
- Maple Chen
- Address
- 101 Lindenwood Dr Ste 225
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 610 4517988
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 | 2022-11-08 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-11-08 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-11-08 |
Proprietary Names
430-RIC
Celesto-RIC-M
Leya-IF-P
Celesto-RIC-S
Leya-RIC-M
AI-2
Leya-IF-P-N
Leya-RIC-S-N
Celesto-IF
Leya-IF-N
Leya-BTE-M-N
Leya-RIC-M-N
Leya-BTE-P-N
Leya-BTE-H-N
Leya-IF
AI-1
610IF
AI-3
LQC-IF-P
Celesto-BTE-M
Leya-BTE-M
Ruby(HA Faceplate)
TINNITUS MASKER
Leya-RIC-S
Celesto-IF-P
Celesto-W-IF-P
Leya-W-RIC-S
Leya-W-BTE-M
Leya-W-IF
Leya-ITC
TW-IF-P
Leya-W-RIC-M
Celesto-W--RIC-M
TW-RIC-C
Celesto-W--BTE-M
TW-RIC-M
TW-IF-C
Sonar Pro
Leya-W-IF-P
Celesto-W-IF
Celesto-W--RIC-S
M-10
ACOMATE M-10
420 BTE
C-118
ACOMATE RECHARGER PLUS
Celesto-BTE-H
ACOMATE RECHARGER
410-BTE-Plus
ACOMATE RECHARGER(C-118)
Leya-BTE-H
ACOMATE ANAYA PLUS
Celesto-BTE-P
Leya-BTE-P
Celesto-W-BTE-H
Leya-W-BTE-P
Celesto-W-BTE-P
Leya-W-BTE-H
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device