# Samsung Electronics Co., Ltd. Mobile eXperience Business (manufacturer, Suwon-si Gyeonggi, KR): 3 new FDA device listings, incl. air-conduction hearing aid software

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Samsung Electronics Co., Ltd. Mobile eXperience Business |
| Owner / operator | Samsung Electronics Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Suwon-si Gyeonggi, KR |
| New listings | 3 |
| Devices | Air-Conduction Hearing Aid Software; Audiometer; Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Product codes | SCR, EWO, QZW |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat, Anesthesiology |
| Brand names | Hearing Aid Feature; Hearing Test Feature; Sleep Apnea Feature (v2) |
| First new listing | 2026-08-18 |
| Latest new listing | 2026-08-18 |
| FDA registration number | 3017616353 |
| Registration expires | 2027-12-31 |

## 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.