# Sunwell Biotech Co., Ltd.

- Location (FDA's records): Echo, OR
- FDA decisions: 1 (2012–2012): 1 510(k) clearance
- Product codes: MEG (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (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
- Inviro Medical Devices, Inc.: 1 (https://510kreport.com/company/inviro-medical-devices)

## Recent decisions
- K121637: Auto-Disable Sterile Safty Syring for Single Use (Oct 25, 2012)

Source page: https://510kreport.com/company/sunwell-biotech