Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044707950

FEI Number

3044707950

Entity Name

COMATRIX TECHNOLOGY VIETNAM COMPANY LIMITED

City/State/Country

Ho Chi Minh City, VN

Establishment Address

No. 74, Lot CN17, Road No. 6, Dong An Industrial Park, Binh Hoa Ward, Ho Chi Minh City, Vietnam, Ho Chi Minh City 75208, VN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COMATRIX TECHNOLOGY VIETNAM COMPANY LIMITED (Owner Number: 10095693)

Owner / Operator Contact Address

No. 74, Lot CN17, Road No. 6, Dong An Industrial Park, Binh Hoa Ward, Ho Chi Minh City, Vietnam, Ho Chi Minh City, VN-SG 75208, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Open Knee Support JOINT, KNEE, EXTERNAL BRACE JOINT, ANKLE, EXTERNAL BRACE Ankle Support SLING, ARM ORTHOSIS, ABDOMINAL STOCKING, MEDICAL SUPPORT Orthosis, Limb Brace ORTHOSIS, CERVICAL ANAEROBIC BOX GLOVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2026-06-02
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2026-06-05
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2026-06-02
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2026-06-02
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2026-06-02
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2026-04-15
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2026-06-02
JTM	Anaerobic Box Glove	Microbiology	Class 1	866.2120	2026-06-05

Official Correspondent

RANDY GU

US Agent Details

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

Related Public Records

Same Entity

COMATRIX TECHNOLOGY VIETNAM COMPANY LIMITED

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

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2183520	Tenacious Holdings Inc	Saint Paul, MN, US
3010239526	Simple Manufacturing DG Ltd	Dongguan City Guangdong, CN
3030683078	HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044707950. Last updated year: 2026. Please use registration number 3044707950 when referencing this establishment in official correspondence.