Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019865496

FEI Number

3019865496

Entity Name

Dongguan Kangda Medical Technology Co., Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Building No.1,MingYing Road No.14,ChangAn Town, Dongguan Guangdong 523800, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan Kangda Medical Technology Co., Ltd (Owner Number: 10082005)

Owner / Operator Contact Address

Building No.1,MingYing Road No.14,ChangAn Town, Dongguan, CN-GD 523800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrocolloid Application Urine Collection Bag Ostomy Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2021-06-03
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2022-11-24
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2022-11-24

Official Correspondent

Xiangping Zhang

US Agent Details

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

Related Public Records

Same Entity

Dongguan Kangda Medical Technology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019865496. Last updated year: 2026. Please use registration number 3019865496 when referencing this establishment in official correspondence.