Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010435017

FEI Number

3010435017

Entity Name

DONG GUAN GANG MEI OPTICAL LIMITED

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

Jin Hai Industrial Area, Wu Xing Village, Xie Gang Town, Dong Guan Guangdong 523590, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dong Guan Gang Mei Optical Limited (Owner Number: 10059055)

Owner / Operator Contact Address

Jin Hai Industrial Area, Wu Xing Village, Xie Gang Town, Dong Guan, CN-GD 523590, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2018-11-26
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2018-11-27

Official Correspondent

TSE SIU LUNG

US Agent Details

Christine DiPalma Business: Hart Specialties, Inc. dba New York Eye Email: cdipalma@newyorkeye.net Phone: (800) 2216966

Related Public Records

Same Entity

Dong Guan Gang Mei Optical 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 3010435017. Last updated year: 2026. Please use registration number 3010435017 when referencing this establishment in official correspondence.