Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005519018

FEI Number

3005519018

Entity Name

WENZHOU DONGTIAN GLASSES MANUFACTURE CO.,LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

#16 JUGAO ROAD, JU GUANG GARDEN, DEZHEN INDUSTRIAL AREA, WENZHOU Zhejiang 325000, CN

Establishment Type(s)

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

Owner / Operator

WENZHOU DONGTIAN IMP&EXP CO., LTD (Owner Number: 9081044)

Owner / Operator Contact Address

No. 3, North Jiaofeng Road, Panfeng, Ouhai Economy Development Zone, WENZHOU, CN-ZJ 325018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

READING GLASSES SPECTACLE LENS OPTICAL LENS Non-surgical Mask Medical Face Shield Disposable Protective Mask SUNGLASSES Safety Goggles Goggles Nursing Goggles Medical Goggles Protective Glasses FRAME

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2005-12-27
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2018-08-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-02
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2005-12-27
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-23
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2005-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

WENZHOU DONGTIAN IMP&EXP 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
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
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
3000180670	Dongguan Rijinyuehui Optical Co.,Ltd	Dongguan Guangdong, CN
3009206998	WORLDWIDE PACKAGING, INC	Livermore, CA, US
3013009176	HYUNDAI SAFETYWEAR CO.	Tainan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005519018. Last updated year: 2026. Please use registration number 3005519018 when referencing this establishment in official correspondence.