CATHWIDE MEDICAL CO.,LTD.

FDA Device Registration & Listing · Shanghai, CN · Registration 3031175043

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
3031175043
FEI Number
3031175043
Entity Name
CATHWIDE MEDICAL CO.,LTD.
City/State/Country
Shanghai, CN
Establishment Address
305A Building 9, No. 1888 Xinjinqiao Road, Shanghai 201206, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Cathwide Medical Co.,Ltd. (Owner Number: 10092546)
Owner / Operator Contact Address
305A Building 9, No. 1888, Xinjinqiao Road, Shanghai, CN-NOTA 201206, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173340
PMA Number
N/A

All Registered Proprietary Names

Disposable silicone Foley catheter All Silicone Foley Catheter with Temperature Sensor Latex Foley Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2025-01-18
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2025-01-18
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2025-01-18

Official Correspondent

XINLEI WEI

US Agent Details

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

Related Public Records

Same Entity

Cathwide Medical 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
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031175043. Last updated year: 2026. Please use registration number 3031175043 when referencing this establishment in official correspondence.
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