Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680369

FEI Number

3004021323

Entity Name

HWA MEEI OPTICAL CO., LTD.

City/State/Country

TAINAN, TW

Establishment Address

28-2 SHA-LUN,, ZHONGSHA VIL., ANDING DIST.,, TAINAN 74555, TW

Establishment Type(s)

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

Owner / Operator

HWA MEEI OPTICAL CO., LTD. (Owner Number: 9008533)

Owner / Operator Contact Address

28-2 SHA-LUEN,, CHUNG SHA VILLAGE, AN TING, TAINAN, TW-TNN 74555, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Decathlon USA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFD	Selector, Color, Spectacle, Lens, Tint	Ophthalmic	Class 1	886.1160	2005-06-27
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2005-06-27
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2005-06-27
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1993-12-06

Official Correspondent

CHIH MING CHEN

US Agent Details

Sean Sullivan Business: Fortress Group, LLC Email: Sean@Kreedom.com Phone: (949) 7703410

Related Public Records

Same Entity

HWA MEEI OPTICAL CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

Similar Registrations

Registration Number	Establishment Name	Location
3003488848	ARGUS VISION INTL. LTD.	WAN CHAI, HONG KONG, HK
9614310	HWA MAO OPTICAL (Xiamen) CO., LTD.	XIAMEN Fujian, CN
3012110814	SHAMIR CANADA	London Ontario, CA
9681443	CERIUM VISUAL TECHNOLOGIES LTD.	TENTERDEN, KENT, GB
3010170531	WENZHOU SUTAR TRADING CO., LTD.	Wenzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680369. Last updated year: 2026. Please use registration number 9680369 when referencing this establishment in official correspondence.