Establishment registration
Sekisui Diagnostics P.E.I. Inc.
FDA establishment registration 8020316 · CHARLOTTETOWN Prince Edward Island, CA
Key facts
| Registration number | 8020316 |
|---|---|
| Establishment name | Sekisui Diagnostics P.E.I. Inc. |
| Owner/operator | Sekisui Diagnostics, LLC |
| Owner/operator number | 10035388 |
| FEI number | 3002806809 |
| Address | 70 Watts Avenue |
| City | CHARLOTTETOWN Prince Edward Island |
| Country | CA |
| Establishment types | Foreign exporter |
| Registration valid through | 2026 |
| Product codes listed | CDQ, CDT, CEK, CEM, CEO, CFJ, CFR, CGA, CGS, CGX, CGZ, CHH, CHI, CIG, CIT, CIX, CJE, CJY, CKA, DCF, DCK, DIC, DKJ, DLJ, JFJ, JFY, JGJ, JGS, JIF, JIS and 17 more |
| Device classes | 1, 2 |
At a glance
- 10–99 Device listings
- 100–999 UDI devices (GUDID)
- Current Registration current
- 1–9 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