Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043106340

FEI Number

3043106340

Entity Name

SUZHOU KANGYOUWEI MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 9, No.28 Xingzhong Road, Wuzhong Economic Development Zone, Suzhou Jiangsu 215000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Kangyouwei Medical Technology Co., Ltd. (Owner Number: 10094574)

Owner / Operator Contact Address

Building 9, No.28 Xingzhong Road, Wuzhong Economic Development Zone, Suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ostomy support belt ostomy accessories (ostomy powder, skin barrier film, adhesive remover, skin barrier ring, ostomy paste, elastic barrier strips, ostomy belt) one-piece ostomy bag, two-piece ostomy bag, ostomy baseplate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2025-12-08
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2025-12-08
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-12-08

Official Correspondent

Xiangshu Suo

US Agent Details

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

Related Public Records

Same Entity

Suzhou Kangyouwei Medical 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-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043106340. Last updated year: 2026. Please use registration number 3043106340 when referencing this establishment in official correspondence.