FDA Device Establishments · JSON-LD · Markdown
FEI 3032859397 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3032859397 |
|---|---|
| Owner / Operator | INNOVEX MEDICAL CO., LTD. (#10092290) |
| Address | 2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China, 1st, 2nd Floor, No.14 Building and 3rd, 4th Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R, Shanghai, 201201, CN |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EYA |
| Regulation § (21 CFR) | 876.5130 |
| Proprietary names | OBSIDIAN(OBSI3515S and OBSI3815S) |
Source: openFDA. Public-domain (CC0).