Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011544981

FEI Number

3011544981

Entity Name

ZHUHAI KANGHONG PLASTIC CO., LTD.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

Building 1, No.362 Dingwan 7 Road Sanzhao Town, Jinwan District, Zhuhai, P.R.C., Zhuhai Guangdong 519000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHUHAI KANGHONG PLASTIC CO., LTD. (Owner Number: 10049272)

Owner / Operator Contact Address

Building 1, No.362 Dingwan 7 Road Sanzhao Town, Jinwan District, Zhuhai, P.R.C., Zhuhai, CN-GD 519000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BABIATORS BABIATORS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-06-24
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2015-05-05
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2021-02-25

Official Correspondent

Theo BERTHUIT

US Agent Details

Ludovic Guillaume Business: otaaki inc. Email: ludovic@otaaki.com Phone: (404) 4023700

Related Public Records

Same Entity

ZHUHAI KANGHONG PLASTIC 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

Registration Number	Establishment Name	Location
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
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 3011544981. Last updated year: 2026. Please use registration number 3011544981 when referencing this establishment in official correspondence.