Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026405350

FEI Number

3026405350

Entity Name

GIA HAO GARMENT EXPORT COMPANY LIMITED - BRANCH OF GLOBAL MANUFACTURING GROUP (VIETNAM)

City/State/Country

HANOI Hung Yen, VN

Establishment Address

PHONG LAM VILLAGE, NAM THUY ANH TOWN, HUNG YEN PROVINCE, VIETNAM, HANOI Hung Yen 06000, VN

Establishment Type(s)

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

Owner / Operator

GLOBAL MANUFACTURING GROUP LIMITED (Owner Number: 9050374)

Owner / Operator Contact Address

RM 1613, 16/F, TREND CENTRE, 29 CHEUNG LEE STREET, CHAIWAN, HONG KONG, HK-NOTA 852, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ERGODYNE PROFLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2003-05-05
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2007-06-07

Official Correspondent

RAYMOND KAI-WAH CHAN

US Agent Details

DEBORAH MILLER Business: TENACIOUS HOLDINGS LIMITED Email: deborah.miller@ergodyne.com Phone: (651) 6429889

Related Public Records

Same Entity

GLOBAL MANUFACTURING GROUP 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 3026405350. Last updated year: 2026. Please use registration number 3026405350 when referencing this establishment in official correspondence.