Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBMC Medical Co., Ltd.
China·CN-MF-000010157
Last updated September 17, 2026
What BMC Medical Co., Ltd. makes
BMC Medical manufactures respiratory support equipment including CPAP and BPAP systems under the RESmart GII brand, non‑invasive ventilators, a respiratory high‑flow therapy device, breathing tubes, and a range of patient interfaces such as full‑face masks, nasal masks and nasal pillow masks (e.g., F6S, P6S, F1B).
The company’s portfolio is classified as Class II, IIa and IIb medical devices and is listed in the European Eudamed database and the U.S. FDA 510(k) registry; BMC Medical is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of devices does BMC Medical Co., Ltd. manufacture?
BMC Medical Co., Ltd. manufactures respiratory support equipment including CPAP and BPAP systems under the RESmart GII brand, non-invasive ventilators, a respiratory high-flow therapy device, breathing tubes, and patient interfaces such as full-face masks, nasal masks, and nasal pillow masks (e.g., F6S, P6S, F1B). These products are designed for respiratory therapy and support in clinical and home settings.
Where is BMC Medical Co., Ltd. based?
BMC Medical Co., Ltd. is based in China, as indicated by the country code CN in the provided data. The company’s headquarters and primary operations are located within China, which informs its regulatory and manufacturing footprint.
In which regulatory registries are BMC Medical’s devices listed?
BMC Medical’s devices are listed in the European Eudamed database and the U.S. FDA 510(k) registry. These listings indicate that the company’s devices have undergone regulatory review for market access in Europe and the United States, though individual device authorizations vary.
How are BMC Medical’s devices classified under medical device regulations?
BMC Medical’s portfolio is classified as Class II, IIa, and IIb medical devices. This classification reflects the risk level associated with the devices, with higher classes indicating greater regulatory scrutiny due to increased potential risk to patients, based on the device’s intended use and technology.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- Room 110 Tower A Fengyu Building, No.115 Fucheng Road, Haidian, Beijing, China
- Website
- bmc-medical.com
- —
- —
- [email protected]
- Phone
- +1-863-226-6285
- PRRC Contact
- Xingwen Chen
- EUDAMED SRN
- CN-MF-000010157
- FDA FEI Number
- 3008566132
- DUNS Number
- 526010310
Catalogue (112)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Full Face Mask | F4(Small) | EUDAMED | Class IIa | Active |
| Nasal Mask | N5B+(Medium) | EUDAMED | Class IIa | Active |
| Full Face Mask | F5(All Size Kit) | EUDAMED | Class IIa | Active |
| RESmart GII BPAP System | Y-20T | EUDAMED | Class IIa | Active |
| Respiratory High-Flow Therapy Device | HT80FU2 | EUDAMED | Class IIa | Active |
| Full Face Mask | F4(Large) | EUDAMED | Class IIa | Active |
| RESmart GII BPAP System | Y-30AT | EUDAMED | Class IIa | Active |
| F2 NV Full Face Mask | F2 NV2(Medium) | EUDAMED | Class IIa | Active |
| iVolve N2 Nasal Mask | BMC-NM2(Medium) | EUDAMED | Class IIa | Active |
| Non-Invasive Ventilator | RV40SU2 | EUDAMED | Class IIa | Active |
| Nasal Mask | N5B+(Small) | EUDAMED | Class IIa | Active |
| CPAP System | G2S C20 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bmc Medical., Ltd. US