Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005669815

FEI Number

3005669815

Entity Name

AMSINO MEDICAL (KUNSHAN) CO., LTD.

City/State/Country

KUNSHAN CITY Jiangsu, CN

Establishment Address

582 SHIPU LIDU ROAD, QIANDENG TOWN, KUNSHAN CITY Jiangsu 215343, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

AMSINO MEDICAL (KUNSHAN) CO., LTD. (Owner Number: 9086542)

Owner / Operator Contact Address

582 LIDU ROAD, QIANDENG TOWN, --, KUNSHAN CITY, JIANGSU PROVINCE, CN-NOTA 215343, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush AMSure Enema bucket set AMSure Enema bag set AMSure PVC Catheter AMSure PVC Intermittent Catheter AMSafe NeuFlo Needleless Connector AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE AMSure ENTERAL DELIVERY PUMP SET WITH SPIKE AMSure Enteral Feeding Set AMSure Enteral Delivery Gravity Set Amsafe IV Administration Set Amsino IV Administration Set AMSINO IV Extension Set AMSafe IV Extension Set AMSure IV Extension Set AMSure IV Administration Set AMSure Vaginal Speculum AMSINO Vaginal Speculum AMSure Cystoscopy & TUR Irrigation Sets AMSure Urine Specimen Container AMSure Specimen Container IV Extension Set IV Administration Set AMSafe-3 IV Set AMSure Urinemeter AMSure Sitz Bath Bag AMSure Shave Prep Kit AMSure Convenience Kit AMSure Red Rubber Catheter Amsino Suction Catheter kit AMSure Suction Connecting Tube Amsino Suction Connecting Tube Ostomy Arch Amsino Forceps AMSure Non-rebreather Oxygen Mask AMSure Mucus Trap AMSure Coiled Suction Catheter AMSure Suction Catheter Kit AMSure Suction Catheter AMSure Suture Removal Kit AMSure Suture Removal Tray AMSure Urethral Catheterization Tray AMSafe® Pre-Filled Normal Saline Flush Syringe AMSure Oxygen Mask AMSure Aerosol Mask AMSINO TRACHEOSTOMY CARE TRAY AMSure TRACHEOSTOMY CARE TRAY Amsino Surgical Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-10-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-09-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-02-07
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2024-02-22
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2020-08-18
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2012-02-10
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2012-02-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-02-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-02-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-02-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-08-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-11-04
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2006-05-16
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2014-03-12
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-02-06
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-05-26
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2006-05-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-02-10
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2012-10-30
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2012-02-20
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2012-02-10
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2006-05-01
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2006-05-16
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2012-02-10
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2017-06-16
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2016-09-27
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2017-02-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-10-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-07-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-10-15
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-11-03
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2013-04-30
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2011-08-18
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2012-03-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-05-16
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2012-08-03
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2018-03-23
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2006-05-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2009-12-10
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2021-03-30
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-07-17
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2024-04-15
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2008-01-08
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2006-05-16
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2019-12-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2012-08-03
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2006-11-08
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2006-11-08
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-05-16

Official Correspondent

Holiven Ji

US Agent Details

Richard Lee Business: AMSINO INTERNATIONAL, INC. Email: holiven_ji@amsino.com Phone: (909) 6065888

Related Public Records

Same Entity

AMSINO MEDICAL (KUNSHAN) 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005669815. Last updated year: 2026. Please use registration number 3005669815 when referencing this establishment in official correspondence.