Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016649599

FEI Number

3016649599

Entity Name

Sanqi (Vietnam) New Material Co., Ltd

City/State/Country

Tan Phuoc 3 Commune Dong Thap, VN

Establishment Address

Lot 118A, Long Giang Industrial Park, Tan Phuoc 3 Commune Dong Thap 93000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sanqi (Vietnam) New Material Co., Ltd (Owner Number: 10065277)

Owner / Operator Contact Address

Lot 118A, Long Giang Industrial Park, Tan Phuoc 3 Commune, VN-45 93000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Apron /Shawl, Bib, Apron Surgical Face Mask Level 1/2/3 Blue, white, pink, green, yellow Medical Bed Sheets, Medical Pillow Cover, Medical Drape,Underpad, Bedding, Disposable, Medical Face Mask Caps, Hood, Surgical Cap, Surgical Cap, Doctor Cap, Nurse Cap, Clip Cap, Protection Hood, Cap, Surgical Check Pants,Sleeve Cover,Cover,Shoe,Operating-Room Accessory, Surgical Apparel; Check Pants, Sleeve Cover Non-Surgical Isolation Gown, Gowns, Coverall, Medical Gown, Isolation Gowns, Protection Grown/Coverall, Lab Coat, Patient Cloth Gauze/Sponge, Nonresorbable For External Use, Medical Gauzes, Medical Gauzes Roll Absorber, Saliva, Paper SURGICAL FACE MASK Dressing Kit For Medical Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWO	Apron, Protective	Radiology	Class 1	892.6500	2020-03-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-07-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-03-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-01-04
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-28
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-28
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-28
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-03-28
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-03-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-03-28

Official Correspondent

Bin Sun

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Sanqi (Vietnam) New Material Co., Ltd

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

Similar Registrations

Registration Number	Establishment Name	Location
3005257704	BEIJING KELIDA MEDICAL EQUIPMENT DEVELOPING CO., LTD	Beijing City, CN
3023265420	KIMLEAD HYGIENE PRODUCTS (HEBEI) CO.,LTD.	Xingtai Hebei, CN
1222742	BURLINGTON MEDICAL, LLC	Newport News, VA, US
2433012	BUSSE HOSPITAL DISPOSABLES	HAUPPAUGE, NY, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016649599. Last updated year: 2026. Please use registration number 3016649599 when referencing this establishment in official correspondence.