Facility
BMC(Dongguan) Medical Co., Ltd.
1 recall(s) on record — most severe on record: Class I.
| FDA Establishment Identifier (FEI) | 3025360937 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | 3/F and 4/F, Building 3, No. 770 Xiecao Road, Xiegang Town Dongguan Guangdong, CN 52300 |
| Registration status | Active · expires 2026 |
| Parent company | BMC Medical Co., Ltd (owner-operator 10040296) |
| Brand names | Rio II Nasal Pillows Interface |
Devices registered here (1)
- Ventilator, Non-Continuous (Respirator)Product code BZD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905
Recalls & enforcement
- Class IOngoing2026-07-15Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Related
- All facilities operated by BMC Medical Co., Ltd
- BMC MEDICAL CO., LTD. (CN)
- BMC (Tianjin) Medical Co., Ltd. (CN)
- BMC (Tianjin) Medical Co., Ltd. (CN)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this facility record at FDA → (opens in a new tab)
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