Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013638008

FEI Number

3013638008

Entity Name

ZHEJIANG SHENGZHUANG INTERNATIONAL TRADE CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.638 Jingyu Road, Louqiao Street, Ouhai District, Wenzhou Zhejiang 325041, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang Shengzhuang International Trade Co., Ltd (Owner Number: 10090274)

Owner / Operator Contact Address

No.638 Jingyu Road, Louqiao Street, Ouhai District, Wenzhou, CN-ZJ 325041, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-03-06
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2024-03-06
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2024-03-06
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-03-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2024-03-06
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2024-03-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-03-06

Official Correspondent

Miaomiao Pan

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Zhejiang Shengzhuang International Trade 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
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3014208300	HITEC MEDICAL CO., LTD	Shanghai, CN
3016458361	SHAOXING REBORN MEDICAL DEVICES CO.,LTD	Shaoxing Zhejiang, CN
3031369651	HSINER CO., LTD.	Taichung City, TW
3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013638008. Last updated year: 2026. Please use registration number 3013638008 when referencing this establishment in official correspondence.