# Tianjin Uwell Medical Device Manufacturing Co., Ltd.

- Location (FDA's records): Tianjin, CN
- FDA decisions: 2 (2016–2017): 2 510(k) clearances
- Product codes: HIF (1), GCJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Unimax Medical Systems, Inc.: 1 (https://510kreport.com/company/unimax-medical-systems)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)

## Firms that cite its devices most
- Wuxi Shukang Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/wuxi-shukang-medical-appliance)

## Its most-cited devices
- K162387: U-IGNITE Bladeless Trocar (2017), cited by 1

## Recent decisions
- K162387: U-IGNITE Bladeless Trocar (Jan 11, 2017)
- K162648: U-Blade Veress Needle (Dec 12, 2016)

Source page: https://510kreport.com/company/tianjin-uwell-medical-device-manufacturing