Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027301746

FEI Number

3027301746

Entity Name

WELL LEAD MEDICAL (HAINAN) CO., LTD.

City/State/Country

Haikou Hainan, CN

Establishment Address

No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157 ,Haikou, Hainan, China, Haikou Hainan 570000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Well Lead Medical (Hainan) Co., Ltd. (Owner Number: 10087515)

Owner / Operator Contact Address

No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157 ,Haikou, Hainan, China, Haikou, CN-HI 570000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wellead Latex Foley Catheter AMSure Silicone Coated Latex Foley Catheter Latex Foley Catheter AMSure Red Rubber Urethral Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2024-06-20
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2024-06-20
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-06-20
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-04-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-03-17
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2023-04-03

Official Correspondent

Xiao Qing Zhao

US Agent Details

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

Related Public Records

Same Entity

Well Lead Medical (Hainan) 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

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3009051888	Applied Medical Distribution Center	Irvine, CA, US
1000393132	COOK INCORPORATED	ELLETTSVILLE, IN, US
1825146	Cook Incorporated	Spencer, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027301746. Last updated year: 2026. Please use registration number 3027301746 when referencing this establishment in official correspondence.