Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038276119

FEI Number

3038276119

Entity Name

GLX MEDICAL DEVICES COMPANY LIMITED

City/State/Country

Bien Hoa Dong Nai, VN

Establishment Address

Factory No.3 Lot E-12, Long Binh Industrial Park (LOTECO), Long Binh Ward, Bien Hoa Dong Nai 810000, VN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

GLX MEDICAL DEVICES COMPANY LIMITED (Owner Number: 10093255)

Owner / Operator Contact Address

Factory No.3 Lot E-12, Long Binh Industrial Park (LOTECO), Long Binh Ward, Bien Hoa, VN-39 810000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alcohol Prep Pad Tongue Depressors (Sterile), Tongue Depressors (Non-Sterile) ACCESSORY SURGICAL APPAREL: Single Use Medical Face Mask Disposable Medical Brush APPLICATOR ABSORBENT TIPPED STERILE; Specimen Collection Swab Sterile, Vaginal PH Swab COVER, MATTRESS (MEDICAL PURPOSES) COVER, SHOE, OPERATING-ROOM Disinfectant, Medical Devices Cotton Ball Transport Swab APPLICATOR, ABSORBENT TIPPED NON STERILE: Specimen Collection Swab Non-Sterile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2026-02-11
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2025-04-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-04-20
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2026-02-11
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2025-04-20
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2025-04-20
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2025-04-20
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-04-20
EFN	Cotton, Roll	Dental	Class 1	872.6050	2026-02-11
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2025-04-20
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-04-20

Official Correspondent

Tina Zhou

US Agent Details

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

Related Public Records

Same Entity

GLX MEDICAL DEVICES COMPANY LIMITED

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038276119. Last updated year: 2026. Please use registration number 3038276119 when referencing this establishment in official correspondence.