Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010805418

FEI Number

3010805418

Entity Name

Sanamedi, Inc.

City/State/Country

Chuo-ku Tokyo, JP

Establishment Address

#601 Nihonbashi Life Science Building, 2-3-11 Nihonbashi-Honcho, Chuo-ku Tokyo 103-0023, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sanamedi, Inc. (Owner Number: 10046345)

Owner / Operator Contact Address

601 Nihonbashi LIfe Science Building, 2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo, JP-13 103-0023, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OZAKI VRec Sizer (13mm, 15mm, 17mm) OZAKI VRec Sizer System (19mm, 21mm, 23mm, 25mm, 27mm, 29mm, 31mm, 33mm, 35mm) OZAKI AVNeo(R) Sizer System OZAKI AVNeo(R) Sizer (31, 33, 35) Heart Valve Sizer and Template OZAKI AVNeo(R) Sizer (13, 15, 17)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2014-03-10

Official Correspondent

Takahiro Uchida

US Agent Details

Kachi Enyinna Business: 510K Technology Group LLC Email: kachi@510ktech.com Phone: (617) 8704055

Related Public Records

Same Entity

Sanamedi, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010805418. Last updated year: 2026. Please use registration number 3010805418 when referencing this establishment in official correspondence.