Data / Medical devices / China / Tianjin Uwell Medical Device Manufacturing Co Ltd
Tianjin Uwell Medical Device Manufacturing Co Ltd: FDA-registered device maker in Tianjin, China, 2 510(k) clearances
Tianjin Uwell Medical Device Manufacturing Co Ltd is registered with the FDA (registration 3014611142) in Tianjin, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 11, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014611142
- Address
- A02, Plant B, No. 278, Hangkong Road, Tianjin Free Trade Zone(Air Port Industrial Park), Tianjin, China, 300308
- Owner or operator
- Tianjin UWell Medical Device Manufacturing Co.,Ltd (10057781)
- Roles
- Manufacturer
- First device listed
- May 24, 2018
- Registered through
- 2027
- Brand names listed
- U-Well
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Pneumoperitoneum Needle | FHO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 11, 2017 | K162387 | U-IGNITE Bladeless Trocar | GCJ | Substantially Equivalent | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | accessdata.fda.gov |
| December 12, 2016 | K162648 | U-Blade Veress Needle | HIF | Substantially Equivalent | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pneumoperitoneum Needle
- All makers of Insufflator, Laparoscopic
- All makers of Laparoscope, General & Plastic Surgery
Updated January 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.