Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008566132

FEI Number

3008566132

Entity Name

BMC MEDICAL CO., LTD.

City/State/Country

Fengtai District Beijing, CN

Establishment Address

Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District Beijing 100073, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BMC Medical Co., Ltd (Owner Number: 10040296)

Owner / Operator Contact Address

Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District, CN-BJ 100073, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242935

PMA Number

N/A

All Registered Proprietary Names

Viva Nasal Mask, Numa Full Face Mask, F2 Single-Patient Vented Full Face Mask Auto CPAP System Siesta full face mask; Siesta nasal mask Rio II Full Face Mask, Rio II Nasal Mask Siesta Contour Nasal Mask Siesta 2 Full Face Mask, Siesta 2 Nasal Mask 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 Rio II Nasal Pillows Interface Respiration Data Management Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-12-13
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2022-12-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2017-09-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-03-10
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-08-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-01-01
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-03-30
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-11-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-03-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-01-21

Official Correspondent

Mingzhao Zhou

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

BMC Medical Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025360937	BMC(Dongguan) Medical Co., Ltd.	Dongguan Guangdong, CN
3026086583	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K033276	Resmed, Ltd.	VPAP III ST-A	2004-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3033530343	BMC INVESTMENT HOLDING LIMITED	Hong Kong, HK
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3042507287	3B MEDICAL INC	W Jefferson, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008566132. Last updated year: 2026. Please use registration number 3008566132 when referencing this establishment in official correspondence.