Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003183807

FEI Number

3003183807

Entity Name

HARADA

City/State/Country

Osaka, JP

Establishment Address

2-10-14, MINAMISEMBA, CHUO-KU,, Osaka 542-0081, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Harada (Owner Number: 10089961)

Owner / Operator Contact Address

2-10-14, MINAMISEMBA, CHUO-KU,, Osaka, JP-27 542-0081, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K854414

PMA Number

N/A

All Registered Proprietary Names

EFER-DUMON BRONCHOSCOPE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-01-26

Official Correspondent

David Rothkopf

US Agent Details

David Rothkopf Email: drothkopf@medicept.com Phone: (617) 8993449

Related Public Records

Same Entity

Harada

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
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003183807. Last updated year: 2026. Please use registration number 3003183807 when referencing this establishment in official correspondence.