FDA Device Establishments · JSON-LD · Markdown
FEI 3025355668 · Manufacture Medical Device · Status: Active
| FEI Number | 3025355668 |
|---|---|
| Owner / Operator | MOLNLYCKE HEALTH CARE US LLC (#8030877) |
| Address | Lot 12A, Jalan Hi-Tech 7, Industrial Zone Phase 2, Kulim Hi-Tech Park, Kulim Kedah, 09090, MY |
| Mandatory US Agent | MOLNLYCKE HEALTH CARE US LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KGO |
| Regulation § (21 CFR) | 878.4460 |
| Proprietary names | Biogel PI Ultratouch G surgical glove; Biogel PI UltraTouch surgical glove; Biogel PI UltraTouch M surgical glove; Biogel PI Pro-Fit surgical glove |
Source: openFDA. Public-domain (CC0).