Establishment registration
PENTAX of America, Inc.
FDA establishment registration 2518897 · MONTVALE, US
Key facts
| Registration number | 2518897 |
|---|---|
| Establishment name | PENTAX of America, Inc. |
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| FEI number | 1000080301 |
| Address | 3 Paragon Drive |
| City | MONTVALE |
| State | NJ |
| Country | US |
| Registration valid through | 2026 |
| Product codes listed | BZD, BZN, EOB, EQL, FAJ, FCG, FCW, FCX, FCY, FEB, FEQ, FLG, FOB, FWF, FWG, GCJ, GCW, GEH, GEI, ITX, IYN, IYO, JRJ, KLA, KLX, KQM, LMB, LMD, MED, NEZ and 6 more |
| Device classes | 1, 2 |
At a glance
- 10–99 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- 10–99 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