Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009961710

FEI Number

3009961710

Entity Name

SAFILO EYEWEAR INDUSTRIES SUZHOU LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

1 Dong Chang Road, Suzhou Industrial Park, Suzhou Jiangsu 215126, CN

Establishment Type(s)

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

Owner / Operator

SAFILO EYEWEAR INDUSTRIES SUZHOU LTD (Owner Number: 10042294)

Owner / Operator Contact Address

1 Dong Chang Road, Suzhou Industrial Park, Suzhou, CN-JS 215126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAFILO FRAME

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-02-05
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2012-11-08

Official Correspondent

Percy Tse

US Agent Details

James Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

SAFILO EYEWEAR INDUSTRIES SUZHOU 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

Similar Registrations

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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 3009961710. Last updated year: 2026. Please use registration number 3009961710 when referencing this establishment in official correspondence.