# Shanghai Eder Medical Technology Inc. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. microscope, operating & accessories, ac-powered, ophthalmic

**Score:** 45/100

| Field | Value |
|---|---|
| Establishment | Shanghai Eder Medical Technology Inc. |
| Role | Manufacturer |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device |
| Location | Shanghai, CN |
| New listings | 2 |
| Devices | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic; Microscope, Operating, Non-Electric, Ophthalmic |
| Product codes | HRM, HRB |
| Device classes | Class I |
| Medical specialties | General, Plastic Surgery |
| Brand names | Ophthalmic Surgical Microscope (SM1000L, SM2000J, SM-2000L, SM-2000Pro,SM-2000Pro A,SM-2000Pro B,; SM-2000Pro D,SM-3000L,SM-3000Pro,SM-3000Pro A,SM-3000Pro B,SM-3000Pro D,SM-1000L/P); SOI4, SOI5, SOI6, SOI7, SOI-2, SOI-2V, SOI-3, SOI-3V); Stereo Optical Inverter, Stereo Indirect Ophthalmoscope (E-sight SIO-2(f200mm), SIO4(f175mm), SIO5(f200mm), |
| First new listing | 2026-09-15 |
| Latest new listing | 2026-09-15 |
| FDA registration number | 3014059828 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.

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: 2026-10-28T20:51:27.468Z.
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.
