Bgss Company Asia Limited

Registered establishment in Zhabei, Shanghai, China. 25 device types.

Registry build 21.09.26

Bgss Company Asia Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Needle, Dental and 23 other device types. Its earliest product listing with the FDA dates from 2011.

Registration

FDA registration record for Bgss Company Asia Limited
Registered name BGSS COMPANY ASIA LIMITED
Status Registered
Registration expires 2026
Registration number 3009219448
FEI number 3009219448
Establishment type Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter

Location

Address of Bgss Company Asia Limited
City Zhabei
Province Shanghai
Address Room 2501, Lindun Building
Postal code 200070
Country China

What It Makes

Device types Bgss Company Asia Limited is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 M3040-BL 2011 439
Applicator, Absorbent Tipped, Non-Sterile Class 1 2011 186
Applicator, Absorbent Tipped, Sterile Class 1 2011 100
Barrier, Control Panel, X-Ray, Movable Class 1 2023 5
Chair, Dental, Without Operative Unit Class 1 Barrier Sleeves 2018 38
Cotton, Roll Class 1 2011 107
Device, Digital Image Storage, Radiological Class 1 Medical Image Storage Device 2018 6
Dispenser, Liquid Medication Class 1 Dental Medical 5oz Cups 2019 86
Evacuator, Oral Cavity Class 1 2011 49
File, Pulp Canal, Endodontic Class 1 2011 53
Garment, Protective, For Incontinence Class 1 2012 181
Holder, Film, X-Ray Class 1 Tray Cover 2018 40
Indicator, Physical/Chemical Sterilization Process Class 2 2018 19
Mask, Scavenging Class 1 Earloop Mask 2015 158
Mouthpiece, Saliva Ejector Class 1 2011 68
Needle, Dental Class 1 2011 56
Non-Surgical Gown Class 1 2011 318
Reamer, Pulp Canal, Endodontic Class 1 2011 10
Syringe, Restorative And Impression Material Class 1 2011 49
Toothbrush, Manual Class 1 2011 244
Tray, Fluoride, Disposable Class 1 2011 22
Tray, Impression, Preformed Class 1 2011 73
Unit, Operative Dental, Accessories Class 1 2011 65
Unit, Syringe, Air And/Or Water Class 1 2011 56
Wrap, Sterilization Class 2 2018 38

Clearances

No clearance names Bgss Company Asia Limited as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Bgss Company Asia Limited or its listings
Clearance Decision date Product code Route Held by
K143637 2015-09-09 FRG Traditional U&U Medical Technology Co., Ltd.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer