Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011111437

FEI Number

3011111437

Entity Name

WENZHOU RAINBOW OPTICAL CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.20 Tianzhushan Rd, Jingkai Zone, Longwan, Wenzhou Zhejiang 325011, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

WENZHOU RAINBOW OPTICAL CO.,LTD (Owner Number: 10049164)

Owner / Operator Contact Address

No.20, Tianzhushan Rd, Jinkai Zone, Longwan, Wenzhou, CN-ZJ 325011, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Protective Eyewear Sunglasses Reading Glasses Spectacle Frame Lens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-04-23
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2015-04-23
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2015-04-23
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2015-04-23
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2015-04-23

Official Correspondent

Amoo Ke

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

WENZHOU RAINBOW 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
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
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

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2522949	PRAIRIE PRODUCTS, INC.	DOVER, PA, US
3014937479	QUANTIGE INDUSTRY SDN BHD	Shah Alam Selangor, MY
3021343301	TAIZHOU YIZHAN OPTICAL GLASSES CO., LTD	Taizhou City Zhejiang, CN
3015005459	TAIZHOU BAILIAN GLASSES MANUFACTURING CO, LTD	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011111437. Last updated year: 2026. Please use registration number 3011111437 when referencing this establishment in official correspondence.