FDA Device Establishments · JSON-LD · Markdown

KYOCERA Medical Corporation Shiga Yasu Plant

FEI 3012119238 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active

FEI Number3012119238
Owner / OperatorKYOCERA Medical Corporation (#9097359)
Address800 Ichimiyake, Yasu-shi Shiga, 520-2362, JP
Mandatory US AgentHastings Regulatory Consulting, LLC
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)DWA, KFM
Regulation § (21 CFR)870.4380, 870.4360
Proprietary namesAFFINITY CP CENTRIFUGAL BLOOD PUMP

External sources

Source: openFDA. Public-domain (CC0).