Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013505405

FEI Number

3013505405

Entity Name

BMC (Tianjin) Medical Co., Ltd.

City/State/Country

Wuqing District Tianjin, CN

Establishment Address

2/F North Area and 3/F, Building No.4, No.1 Xinxing Road, Wuqing District Tianjin 301700, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Rio II Nasal Pillows Interface Viva Nasal Mask, Numa Full Face Mask, F2 Single-Patient Vented Full Face Mask Respiration Data Management Software Luna G3 BPAP System Breathing Tube (L1) 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 II CPAP and Auto CPAP System; Luna II QX CPAP and Auto CPAP System Luna® CPAP and Auto CPAP System

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	2013-12-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-03-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2017-09-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-01-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-03-30
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2020-03-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-01-01
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-08-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-11-17

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
3008566132	BMC MEDICAL CO., LTD.	Fengtai District Beijing, 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

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
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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3042507287	3B MEDICAL INC	W Jefferson, OH, US
3004802249	W&S PLASTICS PTY LTD	Moorebank New South Wales, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013505405. Last updated year: 2026. Please use registration number 3013505405 when referencing this establishment in official correspondence.