Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010032035

FEI Number

3010032035

Entity Name

ZHEJIANG SUNGOOD TECHNOLOGY CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.550 Yinhai Street Economic Development Zone, Hangzhou Zhejiang 310018, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang Sungood Technology Co.,Ltd (Owner Number: 10061611)

Owner / Operator Contact Address

No.550 Yinhai Street Economic Development Zone, Hangzhou, CN-ZJ 310018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Oxygen Cannula Suction Catheters Oxygen Masks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-11-01
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-11-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2019-11-01

Official Correspondent

chunyan Zheng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Zhejiang Sungood Technology Co.,Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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3015084765	GUANG DONG EDA TECHNOLOGY CO., LTD.	Dongguan City Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010032035. Last updated year: 2026. Please use registration number 3010032035 when referencing this establishment in official correspondence.