Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014133483

FEI Number

3014133483

Entity Name

ATEX CO., LTD.

City/State/Country

Osaka, JP

Establishment Address

3-3-24 Nagayoshi-kawanabe, Hirano-ku, Osaka 547-0014, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Reprocess Single-Use Device,Repack or Relabel Medical Device,Foreign Private Label Distributor,Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ATEX Co., Ltd. (Owner Number: 10060111)

Owner / Operator Contact Address

3-3-24 Nagayoshi-kawanabe, Hirano-ku, Osaka, JP-27 547-0014, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lourdes; OHCO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-03-31

Official Correspondent

MAYUMI AKAMATSU

US Agent Details

Cliff Levin Business: FIUS Distributors, LLC Email: finance@fflbrands.com Phone: (303) 5725000

Related Public Records

Same Entity

ATEX Co., Ltd.

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 3014133483. Last updated year: 2026. Please use registration number 3014133483 when referencing this establishment in official correspondence.