FDA Device Establishments · JSON-LD · Markdown

PROFOUND MEDICAL INC.

FEI 3012604011 · 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 Number3012604011
Owner / OperatorProfound Medical Inc. (#10061262)
Address2400 Skymark Avenue, Unit 6, Mississauga Ontario, L4W 5K5, CA
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)QND
Proprietary namesSonalleve MR-HIFU

External sources

Source: openFDA. Public-domain (CC0).