BMC Medical Co., Ltd.
Manufacturer and brand owner in Fengtai District, Beijing, China. 3 device types, 96 products catalogued, 7 clearances.
BMC Medical Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Ventilator, Non-Continuous (Respirator), Ventilator, Continuous, Non-Life-Supporting and 1 other device type. 96 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | BMC MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008566132 |
| FEI number | 3008566132 |
| DUNS | 526010310 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 北京瑞迈特医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 9111010872636740X9 |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Fengtai District |
|---|---|
| Province | Beijing |
| Address | Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road |
| Postal code | 100073 |
| Country | China |
Group
BMC Medical Co., Ltd. is one of 3 plants registered under BMC Medical Co., Ltd.
| Plant | City | Device types |
|---|---|---|
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | 2 |
What It Makes
| 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 | Siesta Contour Nasal Mask, Siesta full face mask; Siesta nasal mask, Siesta 2 Full Face Mask, Siesta 2 Nasal Mask, Rio II Full Face Mask, Rio II Nasal Mask, Luna G3 BPAP System, Respiration Data Management Software and 7 more | 2012 | 18 |
Own-Brand Listings
Clearances
7 clearances name BMC Medical Co., Ltd. as applicant. 6 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.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260171 | 2026-08-14 | CAW | Traditional | This company |
| K253166 | 2026-04-29 | BZD | Traditional | This company |
| K242935 | 2025-01-15 | BZD | Traditional | This company |
| K213169 | 2022-12-05 | MNS | Traditional | This company |
| K211155 | 2022-03-09 | BZD | Traditional | This company |
| K163464 | 2017-09-05 | BZD | Traditional | This company |
| K133009 | 2014-04-23 | BZD | Traditional | This company |
| K212263 | 2022-03-25 | BZD | Traditional | 3B Medical Inc |
| 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 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-15 | Class I | No Marketing Application | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | 20,160 units |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Home non-invasive ventilators, Oxygen concentrators, Ventilation masks, Sleep monitoring devices |
| Certifications | FDA, CE |
| Export markets | 140+ countries and regions |
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.