Hangzhou Acosound Technology Co., Ltd.
Hangzhou Zhejiang, CN
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011350813 | 3011350813 | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. | Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang, Hangzhou Zhejiang 311100 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1976-2025 | AcoSound. Model Number: LW12-BTE-M | 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 manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements. | Class III | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain