Data / Medical devices / China / BMC Medical Co., Ltd.
BMC Medical Co., Ltd.: FDA-registered device maker in Fengtai District Beijing, China, 11 510(k) clearances
BMC Medical Co., Ltd. is registered with the FDA (registration 3008566132) in Fengtai District Beijing, China. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 29, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008566132
- Address
- Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District Beijing, China, 100073
- Owner or operator
- BMC Medical Co., Ltd (10040296)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 29, 2012
- Registered through
- 2027
- Brand names listed
- Alto Full Face Mask, Alto Nasal Mask, Alto Nasal Pillows Interface, Auto CPAP System, Breathing Tube (L1), 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 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2026 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BZD | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| January 15, 2025 | K242935 | Respiration Data Management Software (PAP Link PC) | BZD | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| December 5, 2022 | K213169 | BPAP System | MNS | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| March 25, 2022 | K212263 | Luna G3 BPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| March 9, 2022 | K211155 | Auto CPAP System | BZD | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| September 5, 2017 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | BZD | Substantially Equivalent | Bmc Medical., Ltd. | accessdata.fda.gov |
| September 8, 2016 | K153387 | Luna CPAP and Auto CPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| August 25, 2014 | K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| December 23, 2013 | K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| December 6, 2013 | K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| February 16, 2012 | K112271 | 3B WILLOW | BZD | Substantially Equivalent | 3B Products, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 15, 2026 | 99445 | Class I | Ongoing | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, Continuous, Non-Life-Supporting
Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.