Tianjin Uwell Medical Device Manufacturing Co Ltd
Registered establishment in Tianjin, China. 3 device types, 2 clearances.
Tianjin Uwell Medical Device Manufacturing Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Pneumoperitoneum Needle, Insufflator, Laparoscopic and 1 other device type. Its earliest product listing with the FDA dates from 2018.
3device types registered with the FDA
2510(k) clearances
Registration
| Registered name | TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014611142 |
| FEI number | 3014611142 |
| Establishment type | Manufacturer |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | A02, Plant B, No. 278, Hangkong Road, |
| Postal code | 300308 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Insufflator, Laparoscopic | Class 2 | U-Well | 2018 | 10 |
| Laparoscope, General & Plastic Surgery | Class 2 | U-Well | 2018 | 46 |
| Pneumoperitoneum Needle | Class 2 | U-Well | 2018 | 4 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K162387 | 2017-01-11 | GCJ | Traditional | This company |
| K162648 | 2016-12-12 | HIF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Trocars, Medical devices |
|---|
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.
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