Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009275598

FEI Number

3009275598

Entity Name

WUXI ZONTAI INT'L CORPORATION LTD.

City/State/Country

WUXI Jiangsu, CN

Establishment Address

NO. 455 GUANGRUI RD, WUXI Jiangsu 214011, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

WUXI ZONTAI INT'L CORPORATION LTD. (Owner Number: 10049823)

Owner / Operator Contact Address

NO. 455 GUANGRUI RD, WUXI, CN-JS 214011, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TRIAL LENS SET Wolff Wands, Fixation Stick, Fixation Cube, Brock String Ophthalmic prism bar TRIAL FRAME Maddox Phoria Measure Low-vision magnifier OCCLUDER Sunglasses Vision chart EYE GLASS FRAME OPHTHALMIC POWERED TABLE CONFIRMATION FLIPPER SPECTACLE LENS Accommodative Convergence Ruler Ophthalmic chair Binocular loupe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2015-08-05
NXR	Fixation, Vision Training, Binocular	Ophthalmic	Class 1	886.1290	2026-01-24
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	2016-10-21
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2015-08-05
HKQ	Prism, Rotary, Ophthalmic	Ophthalmic	Class 1	886.1665	2026-01-24
HKC	Spectacle Microscope, Low-Vision	Ophthalmic	Class 1	886.5540	2016-10-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-08-05
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2017-11-10
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2016-10-21
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2015-08-05
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2015-08-05
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2015-08-05
HLE	Ruler, Nearpoint (Punctometer)	Ophthalmic	Class 1	886.1790	2026-01-24
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	2016-10-21
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2016-10-21

Official Correspondent

Fang Li

US Agent Details

James H. Liao Email: fda.agent@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

WUXI ZONTAI INT'L CORPORATION 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
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21
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
3001762432	IKETANI Co., Ltd.	Kiso-gun, Nagano-KEN, JP
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN
8040382	PAUL INSTRUMENTS (INDIA)	CALCUTTA West Bengal, IN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009275598. Last updated year: 2026. Please use registration number 3009275598 when referencing this establishment in official correspondence.