FDA Device Establishments · JSON-LD · Markdown
FEI 3048142405 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3048142405 |
|---|---|
| Owner / Operator | Sakiteya Medical Indonesia (#10096108) |
| Address | Kendal Industrial Area (KIK), Jl. Parang Garuda No. 7A, Tambak, Wonorejo, Kaliwungu, Kendal Regency, Central Jawa, 51372, ID |
| Mandatory US Agent | Regrek LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KXF |
| Regulation § (21 CFR) | 880.6025 |
| Proprietary names | Cotton Bud/Swab |
Source: openFDA. Public-domain (CC0).