Establishment registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD.
FDA establishment registration 3003795116 · ROTKREUZ Zug, CH
Key facts
| Registration number | 3003795116 |
|---|---|
| Establishment name | ROCHE DIAGNOSTICS INTERNATIONAL LTD. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| FEI number | 3003795116 |
| Address | FORRENSTRASSE 2 |
| City | ROTKREUZ Zug |
| Country | CH |
| Establishment types | Repackager/relabeler |
| Registration valid through | 2026 |
| Product codes listed | CDM, CDQ, CDS, CDT, CEK, CEM, CEN, CEO, CET, CFJ, CFN, CFR, CGA, CGX, CGZ, CHH, CHL, CHN, CIC, CIG, CIT, CIX, CJE, CJW, CJX, CKA, CZP, CZW, DAD, DAO and 128 more |
| Device classes | 1, 2, 3, N, U |
At a glance
- 10–99 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