Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010865508

FEI Number

3010865508

Entity Name

WENZHOU EMMA OPTICS CO.,LTD.

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.478, Zhonghui Road, Louqiao Industry Zone, Ouhai District,, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

WENZHOU EMMA OPTICS CO.,LTD. (Owner Number: 10048585)

Owner / Operator Contact Address

No.478, Zhonghui Road, Louqiao Industry Zone, Ouhai District,, Wenzhou, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reading glasses Nonwoven Face Mask Face shield Disposable Medical Face Mask Isolation Boots Mask Face Mask Goggles Isolation gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2018-11-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-31
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-12-25
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

Dike Yu Email: Fdaamerican@gmail.com Phone: (347) 9186666

Related Public Records

Same Entity

WENZHOU EMMA OPTICS CO.,LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3006755718	DONGGUAN YUEHENG OPTICAL CO. LTD.	Dongguan Guangdong, CN
3015534032	BOLLE SAFETY INC	Carlsbad, CA, US
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010865508. Last updated year: 2026. Please use registration number 3010865508 when referencing this establishment in official correspondence.