Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010595570

FEI Number

3010595570

Entity Name

INJEXTECH INC

City/State/Country

TAINAN CITY, TW

Establishment Address

NO.407,SEC.2, BEN TIEN RD., ANNAN DIST., TAINAN CITY 70955, TAIWAN, TAINAN CITY 70955, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INJEXTECH INC (Owner Number: 10055702)

Owner / Operator Contact Address

NO.407,SEC.2, BEN TIEN RD., ANNAN DIST., TAINAN CITY 70955, TAIWAN, TAINAN CITY, TW-TNN 70955, 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
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-09-19
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-09-19
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2017-09-19
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2017-09-19
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2017-09-19

Official Correspondent

Jeffrey Wang Lee

US Agent Details

Scott MacGuffie Email: scott@morrisonna.com Phone: (208) 4716515

Related Public Records

Same Entity

INJEXTECH 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
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

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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 3010595570. Last updated year: 2026. Please use registration number 3010595570 when referencing this establishment in official correspondence.