Ucomfor Scientific Co., Ltd.
Manufacturer and brand owner in Zhangjiagang, Jiangsu, China. 13 device types, 1 product catalogued.
Ucomfor Scientific Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Mask, Scavenging and 11 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | UCOMFOR SCIENTIFIC CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016884033 |
| FEI number | 3016884033 |
| DUNS | 415115657 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏优鼎医疗科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Zhangjiagang |
|---|---|
| Province | Jiangsu |
| Address | Lekun Road, Leyu Town |
| Postal code | 215621 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter And Tip, Suction | Class 2 | SUCTION YANKAUER, Yankauer, non-vented bulb/regular tip, Sterile,Yankauer, vented bulb/regular tip, Suct instr yank blb w/o vent, Yankauer, vented regular tip, Sterile, Latex Free, Suct instr yank reg w vent | 2021 | 70 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary drainage bag 500cc-2000cc , Urinary Leg bag, Drainage Bag | 2021 | 51 |
| Connector, Catheter | Class 1 | Connector | 2022 | 15 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine collector pediatric sterile | 2021 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Urine meters | 2021 | 19 |
| Evacuator, Bladder, Manually Operated | Class 1 | Drainage bags | 2021 | 3 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Enteral Extension Sets, Feeding tubes, Nasoenteric Feeding Tubes | 2022 | 17 |
| Mask, Scavenging | Class 1 | Mask, Scavenging | 2020 | 158 |
| Mask, Surgical | Class 2 | Surgical face mask | 2020 | 125 |
| Respirator, Surgical | Class 2 | Face Mask | 2020 | 118 |
| Speculum, Vaginal, Nonmetal | Class 2 | Vaginal speculum | 2021 | 40 |
| Syringe, Irrigating (Non Dental) | Class 1 | Thumb control piston irrigation syringe 60cc ST, Bulb irrigation syringe 60cc ST, Flat top piston irrigation syringe 60c | 2021 | 110 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Suction conneting tube, Suction Tubing | 2021 | 51 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Vesco | FFD | 4 |
Clearances
No clearance names Ucomfor Scientific 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 disposable medical devices, Non-sterile disposable medical devices, Drainage bags |
|---|
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.