FDA Device Establishments · JSON-LD · Markdown

Polichem SA

FEI 3005427465 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device · Status: Active

FEI Number3005427465
Owner / OperatorPolichem SA (#10036234)
AddressVia Angelo Maspoli 11, Polichem SA, Via Angelo Maspoli 11, 6850 Mendrisio, Switzerland, Mendrisio Ticino, 6850, CH
Mandatory US AgentRegulatory/Quality Management Information Source, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)KMF
Regulation § (21 CFR)880.5090
Proprietary namesGenadur

External sources

Source: openFDA. Public-domain (CC0).