# Soher Med Limited (foreign exporter, Hong Kong, HK): 263 new FDA device listings, incl. cement, dental

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Soher Med Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Hong Kong, HK |
| New listings | 263 |
| Devices | Cement, Dental; File, Periodontic; Material, Tooth Shade, Resin; Point, Abrasive; Material, Impression; Sealant, Pit And Fissure, And Conditioner; Plier, Orthodontic; Applicator, Resin; Plugger, Root Canal, Endodontic; Agent, Tooth Bonding, Resin |
| Product codes | EMA, EMR, EBF, EHL, ELW, EBC, JEX, KXR, EKR, KLE, EBI, EFB, KHR, EJB, EKK |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Dental, General, Plastic Surgery, Radiology |
| Brand names | Dental Cement; File; NX3; dental composite; abrasive; Impression Material; Express; Tooth shade |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-10-22 |
| FDA registration number | 3045857207 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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.