Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012375451

FEI Number

3012375451

Entity Name

SHERN YEONG PRECISE OPTICAL CO., LTD.

City/State/Country

Dongshan Township, Yilan County, TW

Establishment Address

No. 315, Siangjhong Rd, Dongcheng Village, Dongshan Township, Yilan County 269027, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shern Yeong Precise Optical Co., Ltd. (Owner Number: 10050362)

Owner / Operator Contact Address

No. 315, Siangjhong Rd, Dongcheng Village, Dongshan Township, Yilan County, TW-NOTA 269, 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
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-27
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-27
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2015-11-09
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2015-11-09
HKS	Prism, Gonioscopic	Ophthalmic	Class 1	886.1660	2018-12-13

Official Correspondent

Po-Sheng Lai

US Agent Details

Ingrid Liao Business: Fleet Link, Inc. Email: ingrid@fleetlinkinc.us Phone: (508) 2791500

Related Public Records

Same Entity

Shern Yeong Precise 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
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Similar Registrations

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3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3008837339	STRYKER EMEA Supply Chain Services	Venlo Limburg, NL
3007127244	TAIWAN ADVANCED STERILIZATION TECHNOLOGY INC.	Taichung County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012375451. Last updated year: 2026. Please use registration number 3012375451 when referencing this establishment in official correspondence.