# Shanghai Hua EN Industrial Co, Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 2 (2022–2022): 2 510(k) clearances
- Product codes: FXX (2)
- 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
- Hebei Titans Hongsen Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/hebei-titans-hongsen-medical-technology)
- Haian Medigauze Co., Ltd.: 1 (https://510kreport.com/company/haian-medigauze)

## Firms that cite its devices most
- Xiantao Sanda Industrial Co., Ltd.: 1 (https://510kreport.com/company/xiantao-sanda-industrial)

## Its most-cited devices
- K221222: Surgical Face Mask (HNFM0304) (2022), cited by 1

## Recent decisions
- K221838: Surgical Face Mask  (HNFM0103) (Aug 17, 2022)
- K221222: Surgical Face Mask (HNFM0304) (Jun 6, 2022)

Source page: https://510kreport.com/company/shanghai-hua-en-industrial