Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030511423

FEI Number

3030511423

Entity Name

ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.3, Gaoxin Jiu Road,Xiaoshan Economic and Technological Development Zone, Hangzhou Zhejiang 311200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang YiGao Medical Technology Co., Ltd. (Owner Number: 10091102)

Owner / Operator Contact Address

No.3, Gaoxin Jiu Road,Xiaoshan Economic and Technological Development Zone, Hangzhou, CN-ZJ 311200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Syfonix Suction Ureteral Access Sheath Ureteral Access Sheath Circular surgical stapler Disposable Graduated Guidewire Disposable Graduated Guidewire for Urological Treatments Dispoable Stone Collector Disposable Stone Collector Medical Endoscope Image Processor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-09-18
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2025-01-19
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-10-17
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-10-17
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-09-18
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2024-10-17

Official Correspondent

Zongzhi Chai

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Zhejiang YiGao Medical Technology 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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3035480112	SEPLOU (ZHUHAI) CO.,LTD.	Zhuhai Guangdong, CN
3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA
3032959393	CALYXO, INC.	Pleasanton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030511423. Last updated year: 2026. Please use registration number 3030511423 when referencing this establishment in official correspondence.