Amsino Medical (Kunshan) Co., Ltd.
Registered establishment in Kunshan, Jiangsu, China. 53 device types.
Amsino Medical (Kunshan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Enema Kit and 51 other device types. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | AMSINO MEDICAL (KUNSHAN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005669815 |
| FEI number | 3005669815 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | 582 SHIPU LIDU ROAD, QIANDENG TOWN |
| Postal code | 215343 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | 2025 | 33 | |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | 2016 | 30 | |
| Appliance, Colostomy, Disposable | Class 1 | Ostomy Arch | 2012 | 8 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | AMSure Extension Tube, AMSure Leg Bag | 2012 | 52 |
| Basin, Emesis | Class 1 | 2012 | 65 | |
| Bath, Sitz, Nonpowered | Class 1 | AMSure Sitz Bath Bag | 2012 | 22 |
| Bottle, Collection, Vacuum | Class 2 | 2020 | 88 | |
| Cannula, Nasal, Oxygen | Class 1 | 2012 | 97 | |
| Catheter And Tip, Suction | Class 2 | AMSure Suction Catheter, AMSure Coiled Suction Catheter, AMSure Suction Catheter Kit | 2007 | 70 |
| Catheter Care Tray | Class 2 | 2017 | 12 | |
| Catheter, Intravascular, Diagnostic | Class 2 | 2018 | 11 | |
| Catheter, Retention Type, Balloon | Class 2 | 2018 | 17 | |
| Catheter, Straight | Class 2 | AMSure PVC Intermittent Catheter, AMSure PVC Catheter | 2012 | 21 |
| Catheter, Ureteral, Gastro-Urology | Class 2 | AMSure Red Rubber Catheter | 2012 | 4 |
| Catheters, Suction, Tracheobronchial | Class 1 | Amsino Suction Catheter kit | 2016 | 93 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Calculi Strainer | 2012 | 51 |
| Connector, Catheter | Class 1 | 5 in 1 connector, SIMS Connector | 2012 | 15 |
| Container, Liquid Medication, Graduated | Class 1 | 2006 | 68 | |
| Container, Specimen, Non-Sterile | Class 1 | AMSure Specimen Container | 2008 | 115 |
| Container, Specimen, Sterile | Class 1 | AMSure Specimen Container, AMSure Urine Specimen Container | 2006 | 79 |
| Device, Occlusion, Umbilical | Class 1 | Amsino Umbilical Cord Clamp | 2012 | 18 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | AMSure Urinemeter | 2012 | 19 |
| Douche Apparatus, Vaginal, Therapeutic | Class 1 | 2013 | 20 | |
| Dressing, Wound, Drug | Class U | AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush | 2018 | 48 |
| Enema Kit | Class 1 | AMSure Enema bucket set, AMSure Enema bag set | 2012 | 24 |
| Enteral Administration Kit (Adult & Pediatric) | Class 2 | 2017 | 7 | |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | 2024 | 13 | |
| Foley Catheter Kit (Excludes Hiv Testing) | Class 2 | 2018 | 2 | |
| Forceps | Class 1 | Amsino Forceps | 2006 | 99 |
| General Surgery Tray | Class 2 | Amsino Tracheostomy Care Tray, AMSure TRACHEOSTOMY CARE TRAY, Medline General Surgery Tray | 2006 | 24 |
| I.V. Start Kit | Class 2 | Amisno I.V. Start Kit, AMSure I.V. Start Kit | 2010 | 7 |
| Irrigation Kit (Wounds) | Class 1 | 2017 | 1 | |
| Kit, Surgical Instrument, Disposable | Class 1 | AMSure Shave Prep Kit, AMSure Convenience Kit, Amsino Tracheostomy Care Tray, AMSure TRACHEOSTOMY CARE TRAY | 2006 | 67 |
| Mask, Oxygen | Class 1 | AMSure Aerosol Mask, AMSure Oxygen Mask | 2012 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | AMSure Non-rebreather Oxygen Mask | 2012 | 72 |
| Nebulizer (Direct Patient Interface) | Class 2 | Amsure Nebulizer | 2012 | 42 |
| Needle, Hypodermic, Single Lumen | Class 2 | 2009 | 71 | |
| Pump, Infusion, Enteral | Class 2 | 2021 | 5 | |
| Saline, Vascular Access Flush | Class 2 | AMSafe® Pre-Filled Normal Saline Flush Syringe | 2019 | 10 |
| Set, Administration, Intravascular | Class 2 | Amsino IV Administration Set, Amsafe IV Administration Set, AMSure IV Administration Set, AMSINO IV Extension Set, AMSafe IV Extension Set, AMSure IV Extension Set and 5 more | 2011 | 49 |
| Shield, Nipple | Class 1 | 2017 | 15 | |
| Speculum, Vaginal, Nonmetal | Class 2 | AMSINO Vaginal Speculum, AMSure Vaginal Speculum | 2006 | 40 |
| Suture Removal Kit | Class 1 | AMSure Suture Removal Kit, AMSure Suture Removal Tray | 2008 | 12 |
| Syringe, Irrigating (Non Dental) | Class 1 | Enteral Feeding Syringe, Ear/Ulcer Syringe, Bulb Irrigation Syringe, Irrigation Kit, Irrigation Syringe, Enteral Irrigation Kit and 10 more | 2006 | 110 |
| Syringe, Piston | Class 2 | 2009 | 60 | |
| System, Irrigation, Urological | Class 2 | AMSure Cystoscopy & TUR Irrigation Sets | 2012 | 8 |
| Tracheobronchial Suction Catheter Kit | Class 1 | 2018 | 9 | |
| Trap, Sterile Specimen | Class 2 | AMSure Mucus Trap | 2006 | 19 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | AMSure Foley Insertion Tray, AMSure Catheterization Tray, AMSure Urethral Catheterization Tray | 2006 | 11 |
| Tray, Surgical | Class 1 | Amsino Surgical Tray | 2006 | 36 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | AMSure Suction Connecting Tube, Amsino Suction Connecting Tube | 2011 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Amsure Enteral Delivery Pump SET With Spike, AMSure Enteral Feeding Set, AMSure Enteral Delivery Gravity Set | 2012 | 25 |
| Tubing, Pressure And Accessories | Class 1 | Aerosol Tubing | 2014 | 45 |
Clearances
No clearance names Amsino Medical (Kunshan) Co., Ltd. as applicant. 21 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220267 | 2022-10-07 | FPA | Traditional | Amsino Medical Inc. |
| K213522 | 2022-03-22 | NGT | Traditional | Amsino Medical Inc. |
| K200051 | 2020-09-25 | LZH | Traditional | Amsino Medical Inc. |
| K183473 | 2019-07-12 | NGT | Traditional | Amsino Medical Inc. |
| K181423 | 2018-09-07 | FRO | Traditional | Amsino Medical Inc. |
| K173665 | 2018-09-05 | FPA | Traditional | Amsino Medical Inc. |
| K181814 | 2018-09-04 | EZL | Traditional | Amsino Medical Inc. |
| K171857 | 2018-03-30 | PNR | Traditional | Amsino Medical Inc. |
| K101958 | 2010-09-29 | FPA | Special | Amsino Medical Inc. |
| K093773 | 2010-03-10 | FPA | Special | Amsino Medical Inc. |
| K091306 | 2009-08-21 | EZD | Special | Amsino Medical Inc. |
| K070873 | 2007-12-19 | LJH | Traditional | Amsino Medical Inc. |
| K070411 | 2007-10-01 | CAF | Traditional | Amsino Medical Inc. |
| K061039 | 2006-06-29 | FMF | Traditional | Amsino Medical Inc. |
| K050656 | 2005-05-02 | MCZ | Traditional | Amsino Medical Inc. |
| K050654 | 2005-05-02 | LRS | Traditional | Amsino Medical Inc. |
| K030293 | 2004-02-04 | EYB | Traditional | Amsino Medical Inc. |
| K030664 | 2003-05-23 | FCM | Traditional | Amsino Medical Inc. |
| K023276 | 2002-12-09 | LRO | Traditional | Amsino Medical Inc. |
| K992719 | 2000-01-12 | KNT | Traditional | Amsino Medical Inc. |
| K951528 | 1995-05-11 | HIB | Traditional | Amsino Medical Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Employees | 535 |
| Main products | Prefilled syringes, Sterile water and saline solutions, AMSafe medication delivery systems, AMSure enteral feeding systems, Respiratory therapy systems |
| Certifications | ISO 9001 |
| Export markets | Worldwide |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.