Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029995792

FEI Number

3029995792

Entity Name

CHANGZHOU TONGCHUANG MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building A1, Building D3, Hutang Science and Technology Industrial Park, Hutang Town, Wujin District, Changzhou Jiangsu 213161, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Changzhou Tongchuang Medical Instrument Technology Co., Ltd. (Owner Number: 10088894)

Owner / Operator Contact Address

Building A1, Hutang Science and Technology Industrial Park, Hutang Town, Wujin District, Changzhou, CN-JS 213161, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Skin Staplers Disposable Skin Staplers Disposable Skin Staplers Disposable Anorectal Ligation Devices and Cartridges

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2023-10-19
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-10-19
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2023-10-19
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2023-10-19

Official Correspondent

TIAN XIA

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Changzhou Tongchuang Medical Instrument Technology 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029995792. Last updated year: 2026. Please use registration number 3029995792 when referencing this establishment in official correspondence.