Facility

HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.

1 recall(s) on record — most severe on record: Class III.

Key facts

1recalls · worst Class III

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011350813
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang Hangzhou Zhejiang, CN 31110
Registration status	Active · expires 2026
Parent company	Hangzhou Acosound Technology Co., Ltd. (owner-operator 10053274)
Brand names	Leya-W-BTE-P; Celesto-W-BTE-H; Leya-W-BTE-H; Celesto-W-BTE-P

Activity by year

Recalls (1)

Devices registered here (1)

Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Product code OSM (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3305

Recalls & enforcement

Class IIIOngoing2025-04-25
Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the …

All facilities operated by Hangzhou Acosound Technology Co., Ltd.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. (FEI 3011350813) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011350813-hangzhou-acosound-technology-co-ltd/

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