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Amsino Medical (shanghai) Co., Ltd.: FDA-registered device maker in Shanghai, China, 9 510(k) clearances

Name: Amsino Medical (shanghai) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Amsino Medical (shanghai) Co., Ltd. is registered with the FDA (registration 3005515211) in Shanghai, China. It lists 22 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 1, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Amsino Medical (shanghai) Co., Ltd.

FDA registration number: 3005515211
Address: Building No. 1-3, 16, Lane 355, Huazhe Road Songjiang Export Processing Zone, Shanghai, China, 201613
Owner or operator: AMSINO MEDICAL (SHANGHAI) CO., LTD. (9080886)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: December 21, 2005
Registered through: 2026
Brand names listed: AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER, AMSafe I.V. Extension Set, AMSafe IV Administration Set, AMSafe-3 IV Administration Set, AMSure 100% Silicone Foley Catheter, AMSure Hydrophilic Coude Latex Fole, AMSure Hydrophilic Latex Foley Cath, AMSure Red Rubber Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Contract manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Cap, Device Disinfectant	QBP	2	Contract manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Contract manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Contract manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dental Hygiene Kit	NXZ	1	Contract manufacturer	accessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	FFG	2	Contract sterilizer	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Contract manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Contract manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Contract sterilizer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Tracheostomy Cleaning Tray	OGV	2	Contract manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Uroflowmeter	EXY	2	Contract sterilizer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 1, 2018	K181445	AMSure Hydrophilic Intermittent Catheter	EZD	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
September 29, 2010	K101958	AMSINO I.V. ADMINISTRATION AND EXTENSION SETS	FPA	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
September 13, 2010	K101824	AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER	EZL	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
March 10, 2010	K093773	AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS	FPA	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
August 10, 2009	K091699	AMSURE HYDROPHILIC LATEX FOLEY CATHETER	EZL	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
June 28, 2005	K051059	AMSURE 100% SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
February 4, 2004	K030293	AMSURE RED RUBBER URETHRAL CATHETER	EYB	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
October 29, 2003	K030120	AMSURE FOLEY CATHETER	EZL	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
May 11, 1995	K951528	AMSINO DISPOSABLE VIGINAL SPECULUM	HIB	Substantially Equivalent	Amsino Intl., Inc.	accessdata.fda.gov

Compare with other makers

Updated October 1, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.