Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010772972

FEI Number

3010772972

Entity Name

SHI-ATEX CO.,LTD

City/State/Country

Izumiotsu Osaka, JP

Establishment Address

5-3 Ozushima-cho, Izumiotsu Osaka 5950074, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SHI-ATEX Co.,Ltd (Owner Number: 10045205)

Owner / Operator Contact Address

5-3 Ozushima-cho, Izumiotsu, JP-27 5950074, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OE-A65

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-10-17

Official Correspondent

No official correspondent registered.

US Agent Details

Kenneth Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

SHI-ATEX Co.,Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11

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3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010772972. Last updated year: 2026. Please use registration number 3010772972 when referencing this establishment in official correspondence.