# Beurer Far East Ltd. (foreign exporter, Hong Kong SAR, HK): 12 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Beurer Far East Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Foreign Private Label Distributor |
| Location | Hong Kong SAR, HK |
| New listings | 12 |
| Devices | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning; Electrode, Cutaneous; Media, Electroconductive; Unit, Oral Irrigation; Humidifier, Non-Direct Patient Interface (Home-Use) |
| Product codes | NUH, NGX, GXY, GYB, EFS, KFZ |
| Device classes | Class I, Class II |
| Medical specialties | Neurology, Physical Medicine, Dental, Anesthesiology |
| Brand names | EM19 CVS; EM44CM; CEM44; EM44 CVS; EM49 Life; EM49; EM19 RP CVS; EM50 RP |
| First new listing | 2026-06-08 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 3012134907 |
| Registration expires | 2026-12-31 |

## Why this score
- 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.