FDA Device Establishments · JSON-LD · Markdown
FEI 3007125265 · Manufacture Medical Device · Status: Active
| FEI Number | 3007125265 |
|---|---|
| Owner / Operator | HOYA MEDICAL SINGAPORE PTE LTD (#10026402) |
| Address | 10 Biopolis Road #04-01/06, Chromos, Singapore Central Singapore, 138670, SG |
| Mandatory US Agent | Hoya Surgical Optics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HQL |
| Regulation § (21 CFR) | 886.3600 |
| Proprietary names | iSert Preloaded IOL System (Model No. 251); iSert Preloaded IOL System (Model No. 250); iSert Preloaded IOL System (Model No. 230); IPure B3PC; IPure B1PY; IPure B1PC; PreVue C; IPure B3PY; iSert Preloaded IOL System (Model PY-60AD); iSert 255 |
Source: openFDA. Public-domain (CC0).