Establishment registration
ROCHE DIAGNOSTICS GMBH
FDA establishment registration 9610529 · PENZBERG Bavaria, DE
Key facts
| Registration number | 9610529 |
|---|---|
| Establishment name | ROCHE DIAGNOSTICS GMBH |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| FEI number | 3002806560 |
| Address | NONNENWALD 2 |
| City | PENZBERG Bavaria |
| Country | DE |
| Registration valid through | 2026 |
| Product codes listed | CDQ, CDT, CEK, CEM, CEO, CET, CFJ, CFN, CFR, CGN, CGX, CGZ, CHH, CHN, CIC, CIG, CIT, CIX, CJE, CJW, CJX, CKA, CZP, CZW, DAD, DAO, DBF, DBI, DCF, DCN and 79 more |
| Device classes | 1, 2, 3, U |
At a glance
- 1–9 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