Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017041963

FEI Number

3017041963

Entity Name

MB REGENTOX VIETNAM TRADING SERVICE COMPANY LIMITED

City/State/Country

Ho Chi Minh City, VN

Establishment Address

No.1, No.4A Street, An Lac Ward, Ho Chi Minh City 700000, VN

Establishment Type(s)

Manufacture Medical Device,Foreign Private Label Distributor

Owner / Operator

MB Regentox Vietnam Trading Service Company Limited (Owner Number: 10074869)

Owner / Operator Contact Address

No.1, No.4A Street, An Lac Ward, Ho Chi Minh City, VN-SG 700000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REGENTOX ISOLATION GOWN, REGENTOX SURGICAL GOWN REGENTOX SHOES COVER REGENTOX HEAD COVER, BOUFFANT CAP REGENTOX GOWN, GLOVES, FACE MASK, SHOE, HEAD COVER, COTTON REGENTOX FLOSS DENTAL REGENTOX GAUZE/ SPONGE REGENTOX TONGUE DEPRESSOR REGENTOX SURGICAL GAUZE/ SPONGE REGENTOX COOLING/ HEATING/ WARMING PATCH, REGENTOX COOLING/ HEATING/ WARMING GEL PATCH REGENTOX GOWN REGENTOX DISPOSABLE LATEX GLOVES REGENTOX DISPOSABLE POWDER FREE LATEX GLOVES, REGENTOX DISPOSABLE POWDER FREE NITRILE GLOVES REGENTOX FACE MASK, REGENTOX SURGICAL FACE MASK REGENTOX SPECIMEN CONTAINER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-10-23
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2023-01-15
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-01-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-06-02
JES	Floss, Dental	Dental	Class 1	872.6390	2023-07-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-01-24
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2024-05-03
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-01-24
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-12-30
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-02
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2020-10-28
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2020-10-23
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-06-02
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-12-30

Official Correspondent

Hoang Yen Dang

US Agent Details

Theresa Quach Email: Tquach@ltempo.com Phone: (949) 3316913

Related Public Records

Same Entity

MB Regentox Vietnam Trading Service Company 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3011276959	PATIENTSTYLE MEDICAL LLC	San Leandro, CA, US
3014683120	JMU DENTAL, INC	Fullerton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017041963. Last updated year: 2026. Please use registration number 3017041963 when referencing this establishment in official correspondence.