Establishment registration
ORGENTEC DIAGNOSTIKA GMBH
FDA establishment registration 3003232042 · MAINZ Rhineland-Palatinate, DE
Key facts
| Registration number | 3003232042 |
|---|---|
| Establishment name | ORGENTEC DIAGNOSTIKA GMBH |
| Owner/operator | Corgenix Inc. |
| Owner/operator number | 9022938 |
| FEI number | 3003232042 |
| Address | CARL-ZEISS-STRASSE 49-51 |
| City | MAINZ Rhineland-Palatinate |
| Country | DE |
| Establishment types | Manufacturer |
| Registration valid through | 2026 |
| Product codes listed | OQZ |
| Device classes | 2 |
At a glance
- 1–9 Device listings
- None 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