Establishment registration
ROCHE DIAGNOSTICS GMBH
FDA establishment registration 9610126 · MANNHEIM Baden-Wurttemberg, DE
Key facts
| Registration number | 9610126 |
|---|---|
| Establishment name | ROCHE DIAGNOSTICS GMBH |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| FEI number | 3002806559 |
| Address | SANDHOFER STRASSE 116 |
| City | MANNHEIM Baden-Wurttemberg |
| Country | DE |
| Registration valid through | 2026 |
| Product codes listed | CBT, CDD, CDM, CDP, CDQ, CDS, CDT, CDX, CDZ, CEC, CEK, CEM, CEN, CEO, CEP, CET, CEW, CFJ, CFL, CFN, CFP, CFR, CFT, CGA, CGJ, CGN, CGX, CGZ, CHH, CHI and 242 more |
| Device classes | 1, 2, 3, N, U |
At a glance
- 100–999 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