Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038284086

FEI Number

3038284086

Entity Name

TOKYO RESEARCH CENTER FOR ADVANCED SURGICAL TECHNOLOGY CO., LTD.

City/State/Country

Meguro Tokyo, JP

Establishment Address

Tachikawa Building, 2-11-4 Nakane, Meguro Tokyo 152-0031, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Tokyo Research Center for Advanced Surgical Technology Co., (Owner Number: 10093316)

Owner / Operator Contact Address

Tachikawa Building, 2-11-4 Nakane, Meguro, JP-13 152-0031, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

The OZAKI AVPro Sizer Set

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	2025-04-29

Official Correspondent

Shigeyuki Ozaki

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Tokyo Research Center for Advanced Surgical Technology Co.,

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 3038284086. Last updated year: 2026. Please use registration number 3038284086 when referencing this establishment in official correspondence.