FDA Device Establishments · JSON-LD · Markdown
FEI 3038613760 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3038613760 |
|---|---|
| Owner / Operator | GT2 HEALTHCARE SDN.BHD. (#10093482) |
| Address | Lot 5-3, Jalan Hi-Tech 6, Zon Industri Fasa 2, Kulim Hi-Tech Park, Kulim Kedah, 09000, MY |
| Mandatory US Agent | mdi Consultants Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EOQ |
| Regulation § (21 CFR) | 874.4680 |
| Proprietary names | Bronchoscope (flexible or rigid) |
Source: openFDA. Public-domain (CC0).