FDA Device Establishments · JSON-LD · Markdown
FEI 1000581837 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000581837 |
|---|---|
| Owner / Operator | MEDICEL AG (#9027853) |
| Address | Dornierstrasse 11, Altenrhein Sankt Gallen, CH-9423, CH |
| Mandatory US Agent | Volk Optical Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MSS |
| Regulation § (21 CFR) | 886.4300 |
| Proprietary names | 211026 EyeGility Inserter for Preloaded enVista IOLs (2); 211027 EyeGility Inserter for Preloaded enVista IOLs (2.4) |
Source: openFDA. Public-domain (CC0).