FDA Device Establishments · JSON-LD · Markdown

Roche Diabetes Care GmbH

FEI 3011806823 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3011806823
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
AddressSandhofer Strasse 116, Mannheim Baden-Wurttemberg, 68305, DE
Mandatory US AgentRoche Diagnostics Operations Inc
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)JQP
Regulation § (21 CFR)862.2100
Proprietary namescobas IT 1000; cobas Academy; cobas bge link; cobas 8100 Model Alpha; Bulk Loader for cobas p 471; c8100 CRW; c8100 Beta; c8100 SLL; cobas 8100 RSF; cobas 8100 AOB

External sources

Source: openFDA. Public-domain (CC0).