Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009561692

FEI Number

3009561692

Entity Name

EMI FACTORY CO., LTD.

City/State/Country

Kitasaku-gun Nagano, JP

Establishment Address

2794-1 Miyota, Miyota-machi, Kitasaku-gun Nagano 389-0206, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMI Factory Co. Ltd., (Owner Number: 10040323)

Owner / Operator Contact Address

2794-1 Miyota, Miyota-machi, Kitasaku-gun, JP-20 389-0206, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Opthalmic scissors Gastro Needle Holder forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-04-01
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2012-04-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-04-01

Official Correspondent

Noriaki EMI

US Agent Details

Maxwell Sturgis Business: Mitaka USA Inc Email: max@mitakausa.com Phone: (435) 9010515

Related Public Records

Same Entity

EMI Factory 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Similar Registrations

Registration Number	Establishment Name	Location
3004571672	Fischer Surgical Inc.	Imperial, MO, US
2431166	Sklar Corporation	West Chester, PA, US
3015895045	Sklar Corporation - Warehouse	Salisbury, MD, US
3009718267	DIVERSITY CORPORATION FZE	Sharjah Ash Shariqah, AE
3013784566	Berger Surgical Medical Products GmbH	Neuhausen ob Eck Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009561692. Last updated year: 2026. Please use registration number 3009561692 when referencing this establishment in official correspondence.