BMC (Tianjin) Medical Co., Ltd.

Registered establishment in Wuqing District, Tianjin, China. 3 device types.

Registry build 21.09.26

BMC (Tianjin) Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Ventilator, Non-Continuous (Respirator), Ventilator, Continuous, Non-Life-Supporting and 1 other device type. Its earliest product listing with the FDA dates from 2012.

Registration

FDA registration record for BMC (Tianjin) Medical Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3026086583
FEI number 3026086583
Establishment type Contract manufacturer, Specification developer, Manufacturer

Chinese Registration

Chinese company register details for BMC (Tianjin) Medical Co., Ltd.
Chinese legal name 天津怡和嘉业医疗科技有限公司
Source customs registration record

Location

Address of BMC (Tianjin) Medical Co., Ltd.
City Wuqing District
Province Tianjin
Address Building C20, Venture Headquarters Base, No.18 Fuyuan Street
Postal code 301700
Country China

Group

BMC (Tianjin) Medical Co., Ltd. is one of 3 plants registered under BMC Medical Co., Ltd.

Other plants under BMC Medical Co., Ltd
Plant City Device types
BMC Medical Co., Ltd. Fengtai District 3
BMC(Dongguan) Medical Co., Ltd. Dongguan 2

What It Makes

Device types BMC (Tianjin) Medical Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Set, Tubing And Support, Ventilator (W Harness) Class 1 Breathing Tube (L1) 2020 33
Ventilator, Continuous, Non-Life-Supporting Class 2 2022 6
Ventilator, Non-Continuous (Respirator) Class 2 Luna G3 BPAP System, Luna II CPAP and Auto CPAP System; Luna II QX CPAP and Auto CPAP System, Luna® CPAP and Auto CPAP System, Auto CPAP System, Alto Nasal Pillows Interface, Alto Full Face Mask and 7 more 2012 18

Clearances

No clearance names BMC (Tianjin) Medical Co., Ltd. as applicant. 11 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming BMC (Tianjin) Medical Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K253166 2026-04-29 BZD Traditional BMC Medical Co., Ltd.
K242935 2025-01-15 BZD Traditional BMC Medical Co., Ltd.
K213169 2022-12-05 MNS Traditional BMC Medical Co., Ltd.
K212263 2022-03-25 BZD Traditional 3B Medical Inc
K211155 2022-03-09 BZD Traditional BMC Medical Co., Ltd.
K163464 2017-09-05 BZD Traditional BMC Medical Co., Ltd.
K153387 2016-09-08 BZD Traditional 3B Medical Inc
K133769 2014-08-25 BZD Traditional 3B Medical Inc
K131901 2013-12-23 BZD Traditional 3B Medical Inc
K132967 2013-12-06 BZD Special 3B Medical Inc
K112271 2012-02-16 BZD Traditional 3B Products, LLC

From the Company

Published by the company on its own website, not by the FDA.

Information published by BMC (Tianjin) Medical Co., Ltd.
Founded 2001
Employees 300+
Main products CPAP devices, Oxygen concentrators, Non-invasive ventilators, High-flow therapy devices, Polysomnography equipment
Export markets 140+ countries globally

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Tianjin Mastervision Technology Co., Ltd. 2

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer