# Suzhou Minhua Medical Equipment Co.,Ltd. (contract manufacturer, SuZhou Jiangsu, CN): 2 new FDA device listings, incl. cushion, flotation

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Suzhou Minhua Medical Equipment Co.,Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | SuZhou Jiangsu, CN |
| New listings | 2 |
| Devices | Cushion, Flotation; Sleeve, Limb, Compressible |
| Product codes | KIC, JOW |
| Device classes | Class I, Class II |
| Medical specialties | Physical Medicine, Cardiovascular |
| Brand names | Venera 608 Deep Vein Thrombosis (DVT) Prevention System |
| First new listing | 2026-07-09 |
| Latest new listing | 2026-09-11 |
| FDA registration number | 3011529836 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.