Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030128625

FEI Number

3030128625

Entity Name

GOLDEN STAR COMPANY LIMITED - BRANCH

City/State/Country

Uong Bi Quang Ninh, VN

Establishment Address

Phu Thanh Tay Area, Yen Thanh Ward, Uong Bi city, Quang Ninh Province, Vietnam, Uong Bi Quang Ninh 3872025, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Golden Star Company Limited - Branch (Owner Number: 10089442)

Owner / Operator Contact Address

Phu Thanh Tay Area, Yen Thanh Ward, Uong Bi city, Quang Ninh Province, Vietnam, Uong Bi, VN-13 3872025, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VIONIC with FMT Technology VIONIC VIONIC with orthaheel Technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2023-12-07

Official Correspondent

Haley Bui

US Agent Details

Zack Giansante Business: Caleres Email: Zgiansante@caleres.com Phone: (212) 9064284

Related Public Records

Same Entity

Golden Star Company Limited - Branch

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 3030128625. Last updated year: 2026. Please use registration number 3030128625 when referencing this establishment in official correspondence.