Ucomfor Medical Co., Ltd.
Registered establishment in Shanghai, China. 17 device types.
Ucomfor Medical Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Syringe, Ent, Excavator, Ear and 15 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | UCOMFOR MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009104075 |
| FEI number | 3009104075 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 上海禹康医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Rm1208, No.76 Jiuxin Road , Shanghai, 201615, P.R.China |
| Postal code | 201615 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Apparatus, Suction, Single Patient USE, Portable | 2011 | 58 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Leg Bag | 2011 | 52 |
| Brush, Scrub, Operating-Room | Class 1 | surgical brush | 2012 | 42 |
| Catheter And Tip, Suction | Class 2 | Suction Yankauer, non-vented bulb tip, Sterile; Yankauer, non-vented regular tip, Sterile, SUCTION YANKAUER with/without vent | 2011 | 70 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary leg bag, Urinary drainage bag, DRAINAGE BAG | 2011 | 51 |
| Connector, Catheter | Class 1 | Connector, catheter | 2011 | 15 |
| Device, Paste-On For Incontinence, Non-Sterile | Class 1 | Urine collector pediatric 100ml | 2011 | 13 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine collector pediatric st, Urine Collector Sterile, Latex Free | 2011 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Urine meters | 2011 | 19 |
| Evacuator, Gastro-Urology | Class 2 | enema bag | 2013 | 5 |
| Excavator, Ear | Class 1 | Irrigation syringe,Syringe Ear Ulcer | 2011 | 6 |
| Mask, Surgical | Class 2 | Surgical Mask | 2020 | 125 |
| Respirator, Surgical | Class 2 | Surgical Respirator, Mask | 2020 | 118 |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal Speculum | 2022 | 40 |
| Syringe, Ent | Class 1 | Enteral syringe, irrigation syringe | 2011 | 24 |
| Syringe, Irrigating (Non Dental) | Class 1 | Bulb irrigation syringe 60cc, Enteral irrigation syringe 60cc, EAR BULB SYRINGE, Piston enteral irrigation syringe 60cc | 2011 | 110 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction Tubing, Suction Connection Tubing | 2011 | 51 |
Clearances
No clearance names Ucomfor Medical Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K100846 | 2010-08-16 | FXX | Traditional | Intl. Medsurg Connection, Inc. |
| K050887 | 2005-07-11 | HIB | Abbreviated | Zhejiang Gongdong Medical Plastic Factory |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Sterile medical devices, Enteral feeding devices, Disposable medical devices |
|---|---|
| Certifications | BSI certified, ISO 13485 MDR |
| Export markets | Global |
| 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.