FDA Registration Number: 3009219448

Last Validated: February 25, 2024

Status: Valid

Valid2024 U.S. FDA Medical Device Establishment Registration

BGSS COMPANY ASIA LIMITED

Establishment Information

Room 2501, Lindun Building
No.100, North Hengfeng Road
Zhabei Shanghai, CN 200070
86-21-66582821

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Unit, Syringe, Air And/Or Water ECB Valid February 24, 2024

Device Listing

Device Name

Unit, Syringe, Air And/Or Water

Product Code

ECB

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

Cotton, Roll EFN Valid February 24, 2024

Device Listing

Device Name

Cotton, Roll

Product Code

EFN

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

Applicator, Absorbent Tipped, Non-Sterile KXF Valid February 24, 2024

Device Listing

Device Name

Applicator, Absorbent Tipped, Non-Sterile

Product Code

KXF

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Device, Digital Image Storage, Radiological LMB Valid February 24, 2024

Device Listing

Device Name

Device, Digital Image Storage, Radiological

Product Code

LMB

Company Function(s)

Foreign Exporter

Proprietary Name(s)

MEDICAL IMAGE STORAGE DEVICE
Chair, Dental, Without Operative Unit NRU Valid February 24, 2024

Device Listing

Device Name

Chair, Dental, Without Operative Unit

Product Code

NRU

Company Function(s)

Manufacturer, Repackager/Relabeler, Foreign Private Label Distributor

Proprietary Name(s)

BARRIER SLEEVES
Garment, Protective, For Incontinence EYQ Valid February 24, 2024

Device Listing

Device Name

Garment, Protective, For Incontinence

Product Code

EYQ

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Mask, Scavenging KHA Valid February 24, 2024

Device Listing

Device Name

Mask, Scavenging

Product Code

KHA

Company Function(s)

Foreign Exporter

Proprietary Name(s)

EARLOOP MASK
Needle, Dental DZM Valid February 24, 2024

Device Listing

Device Name

Needle, Dental

Product Code

DZM

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Tray, Fluoride, Disposable KMT Valid February 24, 2024

Device Listing

Device Name

Tray, Fluoride, Disposable

Product Code

KMT

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Barrier, Control Panel, X-Ray, Movable IWX Valid February 24, 2024

Device Listing

Device Name

Barrier, Control Panel, X-Ray, Movable

Product Code

IWX

Company Function(s)

Manufacturer

Proprietary Name(s)

Indicator, Physical/Chemical Sterilization Process JOJ Valid February 24, 2024

Device Listing

Device Name

Indicator, Physical/Chemical Sterilization Process

Product Code

JOJ

Company Function(s)

Foreign Exporter

Proprietary Name(s)

Tray, Impression, Preformed EHY Valid February 24, 2024

Device Listing

Device Name

Tray, Impression, Preformed

Product Code

EHY

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

File, Pulp Canal, Endodontic EKS Valid February 24, 2024

Device Listing

Device Name

File, Pulp Canal, Endodontic

Product Code

EKS

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Syringe, Restorative And Impression Material EID Valid February 24, 2024

Device Listing

Device Name

Syringe, Restorative And Impression Material

Product Code

EID

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Toothbrush, Manual EFW Valid February 24, 2024

Device Listing

Device Name

Toothbrush, Manual

Product Code

EFW

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Holder, Film, X-Ray EGZ Valid February 24, 2024

Device Listing

Device Name

Holder, Film, X-Ray

Product Code

EGZ

Company Function(s)

Contract Manufacturer, Repackager/Relabeler

Proprietary Name(s)

TRAY COVER
Applicator, Absorbent Tipped, Sterile KXG Valid February 24, 2024

Device Listing

Device Name

Applicator, Absorbent Tipped, Sterile

Product Code

KXG

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Evacuator, Oral Cavity EHZ Valid February 24, 2024

Device Listing

Device Name

Evacuator, Oral Cavity

Product Code

EHZ

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

Mouthpiece, Saliva Ejector DYN Valid February 24, 2024

Device Listing

Device Name

Mouthpiece, Saliva Ejector

Product Code

DYN

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Non-Surgical Gown OEA Valid February 24, 2024

Device Listing

Device Name

Non-Surgical Gown

Product Code

OEA

Company Function(s)

Foreign Exporter, Manufacturer

Proprietary Name(s)

Reamer, Pulp Canal, Endodontic EKP Valid February 24, 2024

Device Listing

Device Name

Reamer, Pulp Canal, Endodontic

Product Code

EKP

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

Dispenser, Liquid Medication KYX Valid February 24, 2024

Device Listing

Device Name

Dispenser, Liquid Medication

Product Code

KYX

Company Function(s)

Manufacturer, Repackager/Relabeler

Proprietary Name(s)

Dental Medical 5oz Cups
Unit, Operative Dental, Accessories NRD Valid February 24, 2024

Device Listing

Device Name

Unit, Operative Dental, Accessories

Product Code

NRD

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

Accessory, Surgical Apparel LYU Valid February 24, 2024

Device Listing

Device Name

Accessory, Surgical Apparel

Product Code

LYU

Company Function(s)

Manufacturer, Foreign Exporter

Proprietary Name(s)

M3040-BL

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