FDA Device Establishments · JSON-LD · Markdown
FEI 3038187456 · Manufacture Medical Device · Status: Active
| FEI Number | 3038187456 |
|---|---|
| Owner / Operator | PT HealthGuard Technologies (#10093198) |
| Address | Jalan Surfaktan Kavling E28, Sei Mangkei, Desa/Kelurahan Kec. Bosar Maligas, Kab., Simalungun Sumatera Utara, 21183, ID |
| Mandatory US Agent | Primemax |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | LZA, OPJ |
| Regulation § (21 CFR) | 880.6250 |
| Proprietary names | Nitrile examination glove |
Source: openFDA. Public-domain (CC0).