Facility
E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3008530360 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | No. 488-1, North Donghu Road, Linping District Hangzhou Zhejiang, CN 31119 |
| Registration status | Active · expires 2026 |
| Parent company | E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. (owner-operator 10055959) |
| Brand names | DOLORCLAST Focused Shock Waves |
Devices registered here (1)
- Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersProduct code PZL · Class II · General, Plastic Surgery · 21 CFR 878.4685
Recalls & enforcement
- Class IIOngoing2024-03-13Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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