GCMEDICA ENTERPRISE LTD. (WUXI)

Registration Details

Registration Name: GCMEDICA ENTERPRISE LTD. (WUXI)
Registration Number: 3007681502
FEI Number: 3007681502
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Loujin Industrial Park,Shuofang
City: Wuxi Jiangsu
Country: CN

Regulatory Submissions

510(k) Number: K182819

Owner / Operator

Firm Name: GCMEDICA ENTERPRISE LTD. (WUXI)
Operator Number: 10028756
Address: Loujin Industrial Park,Shuofang,214143,Jiangsu,China
City: Wuxi
State: CN-NOTA
Postal Code: 214143
Country: CN
Correspondent: Steven Fan

US Agent

Business Name: G&C Medical Technology Inc.
Contact Name: Xinlu Huang
Address: 1775 Tysons Blvd, 5th Floor Mclean, VA 22102, USA
City: McLean
State: VA
ZIP: 22102
Country: US
Email: [email protected]
Phone: 703 7626336

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Tube, Aspirating, Flexible, Connecting	BYY	Class 2	General Hospital	No	2014-09-08
Bath, Sitz, Nonpowered	KTC	Class 1	Physical Medicine	No	2011-02-21
Trap, Sterile Specimen	BYZ	Class 2	General Hospital	No	2016-12-13
Tray, Surgical, Instrument	FSM	Class 1	General, Plastic Surgery	No	2009-03-03
Curette, Uterine	HCY	Class 1	Obstetrics/Gynecology	No	2014-09-08
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	Class 2	General Hospital	No	2018-01-16
Snare, Surgical	GAE	Class 1	General, Plastic Surgery	No	2011-01-26
Catheter And Tip, Suction	JOL	Class 2	General Hospital	No	2009-03-03
Light, Surgical, Accessories	FTA	Class 2	General, Plastic Surgery	No	2016-07-08
Syringe, Irrigating (Non Dental)	KYZ	Class 1	General Hospital	No	2009-03-03
Set, I.V. Fluid Transfer	LHI	Class 2	General Hospital	No	2013-11-08
Urinal	FNP	Class 1	General Hospital	No	2017-03-21
Airway, Oropharyngeal, Anesthesiology	CAE	Class 1	Anesthesiology	No	2011-11-23
System, Irrigation, Urological	LJH	Class 2	Gastroenterology, Urology	No	2009-11-17
Basin, Emesis	FNY	Class 1	General Hospital	No	2012-08-28
Bougie, Eustachian	KBI	Class 1	Ear, Nose, Throat	No	2016-03-21
Syringe, Ent	KCP	Class 1	Ear, Nose, Throat	No	2016-11-16
Hematocrit, Tube, Rack, Sealer, Holder	GHY	Class 2	Hematology	No	2016-01-12
Bottle, Collection, Vacuum	KDQ	Class 2	General Hospital	No	2019-06-20
Cannula, Nasal, Oxygen	CAT	Class 1	Anesthesiology	No	2009-03-10
Tubing, Noninvasive	GAZ	Class 2	General Hospital	No	2009-03-03
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	Class 2	Cardiovascular	No	2013-11-09
Container, Sharps	MMK	Class 2	General Hospital	No	2017-04-27
Mask, Oxygen	BYG	Class 1	Anesthesiology	No	2009-03-10
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	Class 1	Obstetrics/Gynecology	No	2015-09-25
Kit, Surgical Instrument, Disposable	KDD	Class 1	General, Plastic Surgery	No	2012-03-01

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 Vessel Cannual Sharp Container amnio hook

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)