Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013526170

FEI Number

3013526170

Entity Name

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No. 2-1, Changyang Road, Wujin Economic Development Zone, Changzhou Jiangsu 213145, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Vedkang Medical Science and Technology Co.,Ltd (Owner Number: 10053440)

Owner / Operator Contact Address

No. 2-1, Changyang Road, Wujin Economic Development Zone, Changzhou, CN-JS 213145, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Sphincterotome Injection Needle Spray Catheters Non-vascular Guidewires Disposable Grasping Forceps Disposable Endoscopic Hemoclip Stone Extraction Balloon Balloon Inflators Disposable Bite Block Stone Extraction Baskets Dilation Balloons Disposable Cold Snares; Disposable Grasping Forceps with Net Disposable Polyp Snare Polyp Traps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2024-03-31
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-08-01
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2019-10-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-10-23
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2021-06-07
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-05-17
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2024-02-28
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2019-10-23
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2016-12-07
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2023-09-13
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2019-10-23
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2019-10-23
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2022-09-26
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2022-09-26
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2016-12-06

Official Correspondent

Lin Zhang

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Jiangsu Vedkang Medical Science and 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
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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3014769442	Aomori Olympus Co., Ltd. Hirosaki Site	Hirosaki-shi Aomori, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013526170. Last updated year: 2026. Please use registration number 3013526170 when referencing this establishment in official correspondence.