AMSINO MEDICAL (SHANGHAI) CO., LTD.

Registration Details

Registration Name: AMSINO MEDICAL (SHANGHAI) CO., LTD.
Registration Number: 3005515211
FEI Number: 3005515211
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Building No. 1-3, 16, Lane 355, Huazhe Road, Songjiang Export Processing Zone
City: SHANGHAI
Country: CN

Regulatory Submissions

510(k) Number: K030293

Owner / Operator

Firm Name: AMSINO MEDICAL (SHANGHAI) CO., LTD.
Operator Number: 9080886
Address: SONGJIANG EXPORT PROCESSING, ZONE PHASE V, LOT # 1-3
City: SHANGHAI
State: CN-NOTA
Postal Code: 201613
Country: CN
Correspondent: Holiven - Ji

US Agent

Business Name: Amsino International Inc.
Contact Name: Richard Lee
Address: 708 Corporate Center Drive
City: Pomona
State: CA
ZIP: 91768
Country: US
Email: [email protected]
Phone: 909 6265888

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Condenser, Heat And Moisture (Artificial Nose)	BYD	Class 1	Anesthesiology	No	2006-10-26
Catheter, Ureteral, Gastro-Urology	EYB	Class 2	Gastroenterology, Urology	No	2009-10-13
Dental Hygiene Kit	NXZ	Class 1	Dental	No	2021-08-20
Catheter And Tip, Suction	JOL	Class 2	General Hospital	No	2016-09-07
Tube, Aspirating, Flexible, Connecting	BYY	Class 2	General Hospital	No	2009-09-29
Catheter, Retention Type, Balloon	EZL	Class 2	Gastroenterology, Urology	No	2009-09-03
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	Class 2	General Hospital	No	2011-08-12
Cap, Device Disinfectant	QBP	Class 2	General Hospital	No	2012-11-20
Enteral Syringes With Enteral Specific Connectors	PNR	Class 2	Gastroenterology, Urology	No	2024-06-20
Kit, Surgical Instrument, Disposable	KDD	Class 1	General, Plastic Surgery	No	2012-02-10
Filter, Bacterial, Breathing-Circuit	CAH	Class 2	Anesthesiology	No	2007-04-25
Catheter, Straight	EZD	Class 2	Gastroenterology, Urology	No	2024-07-01
Syringe, Irrigating (Non Dental)	KYZ	Class 1	General Hospital	No	2024-06-20
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2013-06-19
Tracheostomy Cleaning Tray	OGV	Class 2	Anesthesiology	No	2014-02-13
Speculum, Vaginal, Nonmetal	HIB	Class 2	Obstetrics/Gynecology	No	2009-08-13
Basin, Emesis	FNY	Class 1	General Hospital	No	2015-04-16
Bottle, Collection, Vacuum	KDQ	Class 2	General Hospital	No	2005-12-21
Catheters, Suction, Tracheobronchial	BSY	Class 1	Anesthesiology	No	2013-01-02
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	FFG	Class 2	Gastroenterology, Urology	No	2022-09-08
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	Class 2	General Hospital	No	2011-07-29
Uroflowmeter	EXY	Class 2	Gastroenterology, Urology	No	2022-09-08

Proprietary Names

Amsino Red Rubber Catheter AMSure Red Rubber Catheter AMSure Suction Connecting Tubing Amsino Suction Connecting Tubing AMSure Hydrophilic Latex Foley Cath AMSure Hydrophilic Coude Latex Fole AMSure Tracheostomy Clean & Care Tray AMSure Tracheostomy Care Kit Amsino Trach Care Tray RenalSense SENSOR TRAY AMSafe-3 IV Administration Set Amsino Amsure Vaginal Speculum AMSure 100% Silicone Foley Catheter Amsino 100% Silicone Foley Catheter Amsino Foley Catheter TWIST EZEVAC SUCTION CANISTER VACUUM COLLECTION CANISTER MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER AMSafe IV Administration Set Amsino IV Administration Set AMSafe I.V. Extension Set SENSOR KIT AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER Abbocath-T

Establishment Types

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