# Sonoscape Medical Corp. (manufacturer, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Sonoscape Medical Corp. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 3 |
| Devices | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic |
| Product codes | ITX, IYN, IYO |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Autra 70 Digital Color Doppler Ultrasound System; Autra 75 Elite Digital Color Doppler Ultrasound System; Autra 65 Digital Color Doppler Ultrasound System; Autra 75 Pro Digital Color Doppler Ultrasound System; Autra Senior Digital Color Doppler Ultrasound System; Autra 70 Elite Digital Color Doppler Ultrasound System; Autra 75 Digital Color Doppler Ultrasound System; Autra 85W Digital Color Doppler Ultrasound System |
| First new listing | 2026-05-25 |
| Latest new listing | 2026-05-25 |
| FDA registration number | 3015525240 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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.