FDA Device Establishments · JSON-LD · Markdown
FEI 3017263724 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3017263724 |
|---|---|
| Owner / Operator | Sys-Mac Automation Engineering Pte LTd (#10091178) |
| Address | 2 Woodlands Sector 1, #05-18, Singapore 738068, Singapore North West, 738068, SG |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | IYO, ITX |
| Regulation § (21 CFR) | 892.1560, 892.1570 |
| Proprietary names | iSR'obot Mona Lisa |
Source: openFDA. Public-domain (CC0).