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Shenzhen Bi-Rich Medical Devices Co., Ltd: FDA-registered device maker in Shenzhen City Guangdong, China, 2 510(k) clearances

Name: Shenzhen Bi-Rich Medical Devices Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Bi-Rich Medical Devices Co., Ltd is registered with the FDA (registration 3011716786) in Shenzhen City Guangdong, China. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 29, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011716786
Address: No. 10, Xinqiao GangZai Road Xinqiao Street, BaoAn District, Shenzhen City Guangdong, China, 518125
Owner or operator: Shenzhen Bi-Rich Medical Devices Co., Ltd. (10049196)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: April 27, 2015
Registered through: 2027
Brand names listed: Compressor Nebulizer, Medline Hudson RCI MICRO-MIST Nebulizer, Nebulizer, Peak Flow Meter

Devices it lists

Device	Product code	Class	Role	Source
Compressor, Air, Portable	BTI	2	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Contract manufacturer	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Contract manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Unit, Filter, Membrane	JRL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Vacuum Powered Body Fluid Collection Kit	OJR	2	Manufacturer	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
May 29, 2026	K252802	Peak Flow Meter (PF-10(BR-PEF231))	BZH	Substantially Equivalent	Shenzhen Bi-Rich Medical Devices Co., Ltd.	accessdata.fda.gov
November 10, 2009	K091272	BESMED JET NEBULIZER BOTTLE SET	CAF	Substantially Equivalent	Besmed Health Business Corp	accessdata.fda.gov

Compare with other makers

Updated May 29, 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.