FDA Device Establishments · JSON-LD · Markdown
FEI 3014059828 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3014059828 |
|---|---|
| Owner / Operator | Shanghai Eder Medical Technology Inc. (#10056006) |
| Address | Room430, Building4, No.512 Wenchuan Road, Baoshan District, Shanghai, 200433, CN |
| Mandatory US Agent | Regrek LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HRM |
| Regulation § (21 CFR) | 878.4700 |
| Proprietary 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) |
Source: openFDA. Public-domain (CC0).