Zhejiang Soudon Medical Technology Co., Ltd.

Manufacturer and brand owner in Hangzhou, Zhejiang, China. 9 device types, 1 product catalogued, 5 clearances.

Registry build 21.09.26

Zhejiang Soudon Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Endoscopic Bite Block, Dislodger, Stone, Biliary and 7 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.

9device types registered with the FDA
1product
5510(k) clearances

Registration

FDA registration record for Zhejiang Soudon Medical Technology Co., Ltd.
Registered name ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
Status Registered
Registration expires 2026
Registration number 3025311469
FEI number 3025311469
DUNS 724990005
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Zhejiang Soudon Medical Technology Co., Ltd.
Chinese legal name 浙江首鼎医学科技有限公司
Unified social credit code 91330110MA2KCFDJ38
Source export sales certificate, Zhejiang medical products administration

Location

Address of Zhejiang Soudon Medical Technology Co., Ltd.
City Hangzhou
Province Zhejiang
Address Room 401, Building 1, No.99, Lvzhou Road
Postal code 311100
Country China

What It Makes

Device types Zhejiang Soudon Medical Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Cleaning Brushes, For Endoscope Class 1 Dispoasble Clean Brush ;Disposable Endoscopic Cleaning Brush 2023 43
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Class 2 Disposable Stone Retrieval Balloon Catheter 2026 4
Dislodger, Stone, Biliary Class 2 Disposable Stone Extraction Basket 2026 5
Endoscopic Bite Block Class 1 Dispoasble Bite Block;Endoscopic Bite Block;Disposable Dental Pad;Disposable Mouth Guard 2023 44
Endoscopic Guidewire, Gastroenterology-Urology Class 2 Disposable Guide Wire 2023 21
Endoscopic Injection Needle, Gastroenterology-Urology Class 2 Disposable Endoscope Injection Needles 2024 23
Forceps, Biopsy, Non-Electric Class 1 Disposable Rotatable Biopsy Forceps/Disposable Biopsy Forceps 2023 44
Hemostatic Metal Clip For The Gi Tract Class 2 Disposable Hemostatic Clips 2024 17
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 Disposable Sphincterotome 2024 7

Own-Brand Listings

Devices catalogued by Zhejiang Soudon Medical Technology Co., Ltd.
Product Code Catalogue numbers
soudon FBK 1

Clearances

510(k) clearances naming Zhejiang Soudon Medical Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K253013 2026-05-08 GCA Traditional This company
K253056 2026-04-03 LQR Traditional This company
K232450 2024-01-26 PKL Traditional This company
K232442 2023-11-09 FBK Traditional This company
K232476 2023-11-07 KNS Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Zhejiang Soudon Medical Technology Co., Ltd.
Founded 2020
Employees 200
Factory area 5000 ㎡
Main products Disposable Biopsy Forceps, Polypectomy Snares, Hemostatic Clips, Endoscope Injection Needles, Stone Extraction Basket
Certifications NMPA, SGS, CFDA, CE/MDR
OEM and ODM Offered

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer