Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043173

FEI Number

1000283119

Entity Name

SUN WELLEN, INC.

City/State/Country

TAIPEI, TW

Establishment Address

137 FU HSING SOUTH RD.,, 15TH FL.-7, SEC. 1, TAIPEI --, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sun Wellen Inc (Owner Number: 8043173)

Owner / Operator Contact Address

15F-7 No. 137 Sec. 1, Fu Hsing S. Rd, 106, TW-TPE TAIPEI CIT, TW

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
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2001-11-19
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2001-11-19

Official Correspondent

Mia#38 Su

US Agent Details

Jean Liu Business: Nutanix Email: jeancurie@gmail.com Phone: (818) 6256414

Related Public Records

Same Entity

Sun Wellen Inc

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
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
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043173. Last updated year: 2026. Please use registration number 8043173 when referencing this establishment in official correspondence.