Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005515211

FEI Number

3005515211

Entity Name

AMSINO MEDICAL (SHANGHAI) CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

Building No. 1-3, 16, Lane 355, Huazhe Road, Songjiang Export Processing Zone, SHANGHAI 201613, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMSINO MEDICAL (SHANGHAI) CO., LTD. (Owner Number: 9080886)

Owner / Operator Contact Address

SONGJIANG EXPORT PROCESSING, ZONE PHASE V, LOT # 1-3, SHANGHAI, CN-NOTA 201613, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093773

PMA Number

N/A

All Registered 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 AMSafe-3 IV Administration Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2006-10-26
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2009-10-13
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2021-08-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2016-09-07
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2009-09-29
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2009-09-03
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2011-08-12
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2012-11-20
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2024-06-20
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-02-10
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-04-25
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-07-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-06-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-06-19
OGV	Tracheostomy Cleaning Tray	Anesthesiology	Class 2	868.5800	2014-02-13
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2009-08-13
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2009-10-13
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2015-04-16
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-07-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2005-12-21
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2012-01-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-05-26

Official Correspondent

Holiven Ji

US Agent Details

Richard Lee Business: Amsino International Inc. Email: holiven_ji@amsino.com Phone: (909) 6265888

Related Public Records

Same Entity

AMSINO MEDICAL (SHANGHAI) 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
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
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-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Similar Registrations

Registration Number	Establishment Name	Location
3012262567	THERMEDIA CORPORATION	Shelton, WA, US
2936999	Covidien	Lafayette, CO, US
3011587055	SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED	Shaoxing Zhejiang, CN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005515211. Last updated year: 2026. Please use registration number 3005515211 when referencing this establishment in official correspondence.