510K Clear
K162387/K162648
Top Premium Quality
-- by LEAN
-- by Zero Defect
-- by UWELL
Core Competency Capability -- Lean Culture -- Building up
2018-01-06
Lean culture and lean manufacturing method establishing since beginning of 2017. It's a long journey for LEAN...
China FDA Device Licenses Issued for Trocar and Veress Needle
2017-04-06
The China FDA has issued the Medical Device License for UWell's disposable trocar and veress needle on Feb., 6, 2017. And Tianjin Uwell got the Chinese Medical Device Manufacturing License (China Medical Device GMP) in Apr. 2017.
US FDA 510k Clearance for Trocar in Jan., 2017
2017-03-06
On Jan., 11, 2017, US FDA 510k cleared our Disposable Trocars with 510k No., K162387
US FDA 510k Clearance for Veress Needle in Dec., 2016
2016-12-30
On Dec., 12, 2016, US FDA 510k cleared our Veress Needle with 510k No., K162648.
QMS (ISO 13485) Establishment and CE Certificate
2016-10-06
With the result of only two minor deviations, we passed the auditing by TUV Rheiland and got the Certificate of ISO 13485 and CE in Sep., 2016.