Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013388519

FEI Number

3013388519

Entity Name

CHANGZHOU LOOKMED MEDICAL INSTRUMENT CO.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building 3 & 5, No.10, Chenghe Road, Lijia Town Industry Zone,Wujin, Changzhou Jiangsu 213176, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Lookmed Medical Instrument Co.,Ltd (Owner Number: 10053361)

Owner / Operator Contact Address

Building 3 & 5, No.10, Chenghe Road, Lijia Town Industry Zone,Wujin, Changzhou, CN-JS 213176, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable protective clothing Disposable protective mask Disposable protective hat Disposable Skin Staplers Disposable Biopsy Forceps Disposable Skin Staplers Disposable trocars

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-26
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-26
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2016-12-13
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2016-11-28
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2016-11-28
DRC	Trocar	Cardiovascular	Class 2	870.1390	2019-12-05

Official Correspondent

Haiyu Hua

US Agent Details

Cancan Huang Business: Osmunda Technology Co., Ltd. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

Changzhou Lookmed Medical Instrument 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
K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	2023-02-22
K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology	2023-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

Similar Registrations

Registration Number	Establishment Name	Location
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3016628950	BALUSTER LLC	Mountain View, AR, US
3016760548	HEALTH SUPPLY US LLC	Mooresville, NC, US
3013311664	UTOPIA TOWELS INC	Plainview, NY, US
3021286079	PURCEL LABS LLC	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013388519. Last updated year: 2026. Please use registration number 3013388519 when referencing this establishment in official correspondence.