Establishment registration
Ortho and Surgical Products Enterprises S.A.
FDA establishment registration 3010452421 · Villa Canales Guatemala, GT
Key facts
| Registration number | 3010452421 |
|---|---|
| Establishment name | Ortho and Surgical Products Enterprises S.A. |
| Owner/operator | DEROYAL INDUSTRIES, INC. |
| Owner/operator number | 1044833 |
| FEI number | 3010452421 |
| Address | KM 20.5 Carretera a Villa Canales |
| City | Villa Canales Guatemala |
| Country | GT |
| Registration valid through | 2026 |
| Product codes listed | BXB, CBH, CCX, DXZ, EFN, EFQ, FMF, FMP, FMQ, FMR, FNL, FOK, FPY, FQM, FRL, FRO, FRQ, FSD, FWZ, FZZ, GAL, GAM, GAP, GAQ, GAR, GAT, GAW, GAX, GAZ, GBW and 45 more |
| Device classes | 1, 2, U |
At a glance
- 10–99 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- None FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database