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BMC 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
LinkedIn: —
Facebook: —
Email: [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)

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Device	Model / Reference	Registries	Class	Status
Non-Invasive Ventilator	RV30FM2	EUDAMED	Class IIa	Active
Non-Invasive Ventilator	RV30FU2	EUDAMED	Class IIa	Active
Nasal Mask	N5AH(Large)	EUDAMED	Class IIa	Active
F2 NV Full Face Mask	F2 NV1(Large)	EUDAMED	Class IIa	Active
BPAP System	G3 B30SV	EUDAMED	Class IIa	Active
Nasal Mask	N5A+(Extra Large)	EUDAMED	Class IIa	Active
Heated Breathing Tube	LH1	EUDAMED	Class IIa	Active
Respiratory High-Flow Therapy Device	H-80A	EUDAMED	Class IIa	Active
BPAP System	G3 B20A	EUDAMED	Class IIa	Active
RESmart GII BPAP System	U-20T	EUDAMED	Class IIa	Active
Nasal Mask	N5A(Small)	EUDAMED	Class IIa	Active
iVolve N2 Nasal Mask	BMC-NM2(Small)	EUDAMED	Class IIa	Active
iVolve F1A Full Face Mask	BMC-FM1A(Large)	EUDAMED	Class IIa	Active
BPAP System	G2S B30VT	EUDAMED	Class IIa	Active
Nasal Mask	N6S(Medium Wide)	EUDAMED	Class IIa	Active
Nasal Mask	N5BH(Medium)	EUDAMED	Class IIa	Active
N4 Nasal Mask	NM4(Medium)	EUDAMED	Class IIa	Active
Respiratory High-Flow Therapy Device	HT90SU2	EUDAMED	Class IIa	Active
Nasal Mask	N6(Small)	EUDAMED	Class IIa	Active
Oxygen Concentrator	SO1 5B	EUDAMED	Class IIb	Active
Disposable Water Chamber	YCX20	EUDAMED	Class IIa	Active
iVolve F1A Full Face Mask	BMC-FM1A(Small)	EUDAMED	Class IIa	Active
BPAP System	G3 B25VT	EUDAMED	Class IIa	Active
Mesh Nebulizer	MN11A	EUDAMED	Class IIa	Active
PolyWatch Portable Sleep Diagnostic System	YH-600B Pro	EUDAMED	Class IIa	Active
Non-Invasive Ventilator	RV30NU2	EUDAMED	Class IIa	Active
Nasal Pillows Interface	P6S	EUDAMED	Class IIa	Active
RESmart GII Auto CPAP System	E-20A-H-O	EUDAMED	Class IIa	Active
Full Face Mask	F6(Small)	EUDAMED	Class IIa	Active
BPAP System	G3 B30VT	EUDAMED	Class IIa	Active
P2 Nasal Pillows Interface	P2	EUDAMED	Class IIa	Active
Heated Humidifier	H60	EUDAMED	Class IIa	Active
Auto CPAP System	G3 A20	EUDAMED	Class IIa	Active
Full Face Mask	F6(Medium)	EUDAMED	Class IIa	Active
Nasal Mask	N5B+(Large)	EUDAMED	Class IIa	Active
Breathing Tube	L1(D19)	EUDAMEDFDA UDI	Class IIa	Active
F1B Full Face Mask	F1B(Small)	EUDAMED	Class IIa	Active
Respiratory High-Flow Therapy Device	HT80SU2	EUDAMED	Class IIa	Active
F1B Full Face Mask	F1B(Medium)	EUDAMED	Class IIa	Active
Full Face Mask	F5(Small)	EUDAMED	Class IIa	Active
Nasal Mask	N5+(All Size Kit)	EUDAMED	Class IIa	Active
iVolve F1A Full Face Mask	BMC-FM1A(Medium)	EUDAMED	Class IIa	Active
N4 Nasal Mask	NM4(All Size Kit)	EUDAMED	Class IIa	Active
RESmart GII BPAP System	T-25T	EUDAMED	Class IIa	Active
Nasal Mask	N5H(Small)	EUDAMED	Class IIa	Active
Non-Invasive Ventilator	R-80C	EUDAMED	Class IIa	Active
Full Face Mask	F6(All Size Kit)	EUDAMED	Class IIa	Active
Nasal Mask	N5AH(All Size Kit)	EUDAMED	Class IIa	Active
Nasal Cannula	NC12S	EUDAMED	Class IIa	Active
RESmart GII BPAP System	U-30T	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Bmc Medical., Ltd. US