FDA Device Establishments · JSON-LD · Markdown

Sanamedi, Inc.

FEI 3010805418 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active

FEI Number3010805418
Owner / OperatorSanamedi, Inc. (#10046345)
Address#601 Nihonbashi Life Science Building, 2-3-11 Nihonbashi-Honcho, Chuo-ku Tokyo, 103-0023, JP
Mandatory US Agent510K Technology Group LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)DTI
Regulation § (21 CFR)870.3945
Proprietary namesOZAKI VRec Sizer (13mm, 15mm, 17mm); OZAKI AVNeo(R) Sizer System; OZAKI VRec Sizer System (19mm, 21mm, 23mm, 25mm, 27mm, 29mm, 31mm, 33mm, 35mm); Heart Valve Sizer and Template; OZAKI AVNeo(R) Sizer (31, 33, 35); OZAKI AVNeo(R) Sizer (13, 15, 17)

External sources

Source: openFDA. Public-domain (CC0).