FDA Device Establishments · JSON-LD · Markdown

Materialise USA, LLC.

FEI 3005718816 · Manufacture Medical Device · Status: Active

FEI Number3005718816
Owner / OperatorMATERIALISE N.V. (#9029485)
Address44650 Helm Court, Plymouth, MI, US
Registration expiry2026
Initial importer flagY
Registered products4
Product codes (top 20)MBH, OIY, OOG, JWH
Regulation § (21 CFR)888.3565, 888.3560
Proprietary namesBespoke Patient Specific Instruments; Materialise TKA Guides; SurgiCase Knee Planner; Materialise Knee Guides; Materialise Knee Planner; Materialise TKA Guide System; Materialise SurgiCase Knee Planner; Materialise SurgiCase Knee Module; Materialise Knee Guide System; Materialise Knee Platform

External sources

Source: openFDA. Public-domain (CC0).