ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3025311469

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025311469
FEI Number
3025311469
Entity Name
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
Room 302-1, Floor 3, Building 4, No. 1 Nangonghe Road, Donghu Street,Linping District, Hangzhou Zhejiang 311100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zhejiang Soudon Medical Technology Co.,Ltd (Owner Number: 10087131)
Owner / Operator Contact Address
Room 302-1, Floor 3, Building 4, No. 1 Nangonghe Road, Donghu Street,Linping District, Hangzhou, CN-ZJ 311100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Guide Wire Disposable Sphincterotome Dispoasble Bite Block;Endoscopic Bite Block;Disposable Dental Pad;Disposable Mouth Guard Disposable Stone Extraction Basket Disposable Hemostatic Clips Disposable Rotatable Biopsy Forceps/Disposable Biopsy Forceps

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-01-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2024-05-12
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2023-02-08
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2026-05-08
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-05-12
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2023-01-16

Official Correspondent

Xiangyong Yu

US Agent Details

Meijuan Lin Email: linmeijuan86@gmail.com Phone: (313) 6103069

Related Public Records

Same Entity

Zhejiang Soudon 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
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17

Similar Registrations

Registration Number Establishment Name Location
3010155661 Synergy Health Sterilisation UK Ltd Thorne Doncaster, GB
3015225571 Merit Medical Asia Company Limited Tsim Sha Tsui, HK
1828132 BOSTON SCIENTIFIC CORPORATION SPENCER, IN, US
3012536737 Merit Medical Canada Ltd. Markham Ontario, CA
2126666 Lake Region Medical CHASKA, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025311469. Last updated year: 2026. Please use registration number 3025311469 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.