Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007681502

FEI Number

3007681502

Entity Name

GCMEDICA ENTERPRISE LTD. (WUXI)

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

Loujin Industrial Park,Shuofang, Wuxi Jiangsu 214143, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GCMEDICA ENTERPRISE LTD. (WUXI) (Owner Number: 10028756)

Owner / Operator Contact Address

Loujin Industrial Park,Shuofang,214143,Jiangsu,China, Wuxi, CN-NOTA 214143, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aspiration Tubing Set Orthopedic Super Sucker Set Water Bag Sitz Bath Bag Mucus Trap TRAY,SURGICAL INSTRUMENT suction canister soft liners / rigid suction canister Suture Retriever Light handle cover Male Urinal I.V FLUID TRANSFER BOUGIE Ear Syringe HOLDER CAT - CANNULA, NASAL, OXYGEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2014-09-08
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2011-02-21
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2016-12-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2009-03-03
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2014-09-08
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2018-01-16
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-01-26
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2009-03-03
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2016-07-08
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2009-03-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-11-08
FNP	Urinal	General Hospital	Class 1	880.6730	2017-03-21
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2011-11-23
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2009-03-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-01-06
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2009-11-17
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2012-08-28
KBI	Bougie, Eustachian	Ear, Nose, Throat	Class 1	874.4175	2016-03-21
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2016-11-16
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	Class 2	864.6400	2016-01-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2019-06-20
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-03-10
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2009-03-03

Official Correspondent

Steven Fan

US Agent Details

Xinlu Huang Business: G&C Medical Technology Inc. Email: info@gcmti.com Phone: (703) 7626336

Related Public Records

Same Entity

GCMEDICA ENTERPRISE LTD. (WUXI)

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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

Registration Number	Establishment Name	Location
3030413693	Medway Supplies Inc	Lake Elsinore, CA, US
1062154	NDH MEDICAL, INC.	Saint Petersburg, FL, US
3010594263	JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.	Shuyang Jiangsu, CN
3015967359	Stryker Instruments	Portage, MI, US
3003902679	ENTER MEDICAL CORPORATION	Chiayi County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007681502. Last updated year: 2026. Please use registration number 3007681502 when referencing this establishment in official correspondence.