Data / Medical devices / China / BGSS Company Asia Limited

BGSS Company Asia Limited: FDA-registered device maker in Zhabei Shanghai, China, 1 510(k) clearance

Name: BGSS Company Asia Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

BGSS Company Asia Limited is registered with the FDA (registration 3009219448) in Zhabei Shanghai, China. It lists 25 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 9, 2015. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch BGSS Company Asia Limited

FDA registration number: 3009219448
Address: Room 2501, Lindun Building No.100, North Hengfeng Road, Zhabei Shanghai, China, 200070
Owner or operator: BGSS COMPANY ASIA LIMITED (10038365)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed: October 9, 2011
Registered through: 2026
Brand names listed: BARRIER SLEEVES, Dental Medical 5oz Cups, EARLOOP MASK, M3040-BL, MEDICAL IMAGE STORAGE DEVICE, TRAY COVER

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Barrier, Control Panel, X-Ray, Movable	IWX	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Foreign private label distributor, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cotton, Roll	EFN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Exporter to the US	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Exporter to the US	accessdata.fda.gov
Mask, Scavenging	KHA	1	Exporter to the US	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Exporter to the US	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
September 9, 2015	K143637	U&U Sterilization Pouch and Roll	FRG	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 9, 2015. 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.