Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009219448

FEI Number

3009219448

Entity Name

BGSS COMPANY ASIA LIMITED

City/State/Country

Zhabei Shanghai, CN

Establishment Address

Room 2501, Lindun Building, No.100, North Hengfeng Road, Zhabei Shanghai 200070, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

BGSS COMPANY ASIA LIMITED (Owner Number: 10038365)

Owner / Operator Contact Address

Rm 2501, Lindun Bldg, No. 100 N. Hengfeng Rd,, Zhabei, CN-SH 200070, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EARLOOP MASK TRAY COVER MEDICAL IMAGE STORAGE DEVICE BARRIER SLEEVES M3040-BL Dental Medical 5oz Cups

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2011-10-09
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2011-10-09
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-10-09
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2015-06-16
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2011-10-09
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2011-10-09
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2011-10-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-10-09
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2018-11-05
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-10-09
EFN	Cotton, Roll	Dental	Class 1	872.6050	2011-10-09
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2012-03-19
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2011-10-09
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2018-08-22
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2018-11-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2011-10-09
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-06-11
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2011-10-09
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-10-09
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2011-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

BGSS COMPANY ASIA LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

Registration Number	Establishment Name	Location
3042158426	INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI	Istanbul, TR
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009219448. Last updated year: 2026. Please use registration number 3009219448 when referencing this establishment in official correspondence.