FDA Device Establishments · JSON-LD · Markdown
FEI 3043535425 · Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3043535425 |
|---|---|
| Owner / Operator | K-One MediTech Sdn. Bhd. (#10095097) |
| Address | 4B, Jalan JPT, Bagan Sekinchan, Sekinchan Selangor, 45400, MY |
| Mandatory US Agent | Registrar corp |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KPY |
| Regulation § (21 CFR) | 892.6500 |
| Proprietary names | Steradian Shield |
Source: openFDA. Public-domain (CC0).