Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028009131

FEI Number

3028009131

Entity Name

GERUN OPTICAL LTD

City/State/Country

Ruian City, Wenzhou Zhejiang, CN

Establishment Address

3F, FengHe Road No.8,Huangshe Village,Mayu Town, Ruian City, Wenzhou Zhejiang 325208, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gerun Optical Ltd (Owner Number: 10089819)

Owner / Operator Contact Address

3F, FengHe Road No.8,Huangshe Village,Mayu Town, Ruian City, Wenzhou, CN-ZJ 325208, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gerun

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2024-01-10

Official Correspondent

Chen Qiu

US Agent Details

Shulin Chen Business: YCC International Corporation Email: shulin@yccic.com Phone: (509) 4323517

Related Public Records

Same Entity

Gerun Optical 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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028009131. Last updated year: 2026. Please use registration number 3028009131 when referencing this establishment in official correspondence.