Amsino Medical (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 22 device types.
Amsino Medical (Shanghai) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Uroflowmeter, Basin, Emesis and 20 other device types. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | AMSINO MEDICAL (SHANGHAI) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005515211 |
| FEI number | 3005515211 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building No. 1-3, 16, Lane 355, Huazhe Road |
| Postal code | 201613 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | 2011 | 30 | |
| Basin, Emesis | Class 1 | 2015 | 65 | |
| Bottle, Collection, Vacuum | Class 2 | Ezevac, Suction Canister, Twist, Vacuum Collection Canister | 2005 | 88 |
| Cap, Device Disinfectant | Class 2 | 2012 | 2 | |
| Catheter And Tip, Suction | Class 2 | 2016 | 70 | |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | Abbocath-T | 2011 | 12 |
| Catheter, Retention Type, Balloon | Class 2 | Amsino Foley Catheter, Amsure 3-WAY Hydrophilic Latex Foley Catheter, Amsino 100% Silicone Foley Catheter, AMSure 100% Silicone Foley Catheter, Medline Silvertouch 100% Silicone Foley Catheter, AMSure Hydrophilic Latex Foley Cath and 1 more | 2008 | 17 |
| Catheter, Straight | Class 2 | 2024 | 21 | |
| Catheter, Ureteral, Gastro-Urology | Class 2 | Amsino Red Rubber Catheter, AMSure Red Rubber Catheter | 2009 | 4 |
| Catheters, Suction, Tracheobronchial | Class 1 | 2013 | 93 | |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | 2006 | 29 | |
| Dental Hygiene Kit | Class 1 | 2021 | 12 | |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Sensor KIT | 2022 | 19 |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | 2024 | 13 | |
| Filter, Bacterial, Breathing-Circuit | Class 2 | 2007 | 15 | |
| Kit, Surgical Instrument, Disposable | Class 1 | AMSure Tracheostomy Care Kit, Amsino Trach Care Tray, AMSure Tracheostomy Clean & Care Tray, RenalSense SENSOR TRAY | 2012 | 67 |
| Set, Administration, Intravascular | Class 2 | AMSafe IV Administration Set, Amsino IV Administration Set, AMSafe-3 IV Administration Set, AMSafe I.V. Extension Set | 2010 | 49 |
| Speculum, Vaginal, Nonmetal | Class 2 | Amsino, Amsure Vaginal Speculum | 2009 | 40 |
| Syringe, Irrigating (Non Dental) | Class 1 | 2024 | 110 | |
| Tracheostomy Cleaning Tray | Class 2 | 2014 | 3 | |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Amsino Suction Connecting Tubing, AMSure Suction Connecting Tubing | 2009 | 51 |
| Uroflowmeter | Class 2 | 2022 | 7 |
Clearances
No clearance names Amsino Medical (Shanghai) Co., Ltd. as applicant. 9 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 |
|---|---|---|---|---|
| K181445 | 2018-10-01 | EZD | Traditional | Amsino Medical Inc. |
| K101958 | 2010-09-29 | FPA | Special | Amsino Medical Inc. |
| K101824 | 2010-09-13 | EZL | Traditional | Amsino Medical Inc. |
| K093773 | 2010-03-10 | FPA | Special | Amsino Medical Inc. |
| K091699 | 2009-08-10 | EZL | Special | Amsino Medical Inc. |
| K051059 | 2005-06-28 | EZL | Traditional | Amsino Medical Inc. |
| K030293 | 2004-02-04 | EYB | Traditional | Amsino Medical Inc. |
| K030120 | 2003-10-29 | EZL | 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 | 2000 |
| Factory area | 100000 |
| Main products | Waste fluid management, Enteral feeding systems, Medication delivery, Respiratory therapy |
| Certifications | FDA |
| 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.