Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010138349

FEI Number

3010138349

Entity Name

CHANGZHOU HEALTH MICROPORT MEDICAL DEVICE CO.,LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No. 11 Tuanjie Road, Tianning District,, Changzhou Jiangsu 213018, CN

Establishment Type(s)

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

Owner / Operator

CHANGZHOU HEALTH MICROPORT MEDICAL DEVICE CO.,LTD. (Owner Number: 10046883)

Owner / Operator Contact Address

No. 11 Tuanjie Road, Tianning District,, Changzhou, CN-JS 213018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multi-chamber polyp Trap Cleaning Brush Hemorrhoidal Multi-Band Ligator with Anoscope Stone Extraction Baskets Bite Block Bougie Dilator Disposable Grasping Forceps Ligatures Endoscopic Loop

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2016-09-07
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-06-30
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2016-09-07
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2016-09-17
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2014-06-30
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2020-03-28
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-09-17
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2016-09-07

Official Correspondent

Jin Gong

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

CHANGZHOU HEALTH MICROPORT MEDICAL DEVICE 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
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17

Similar Registrations

Registration Number	Establishment Name	Location
3010300504	SERRES OY	Kauhajoki as Pirkanmaa, FI
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3019794450	KIEN AN TRANSPOWER COMPANY LIMITED	HO CHI MINH CITY Tay Ninh, VN
3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010138349. Last updated year: 2026. Please use registration number 3010138349 when referencing this establishment in official correspondence.