Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003184529

FEI Number

3003184529

Entity Name

MEDIKIT CO., LTD.

City/State/Country

BUNKYO KU Tokyo, JP

Establishment Address

1-13-2 YUSHIMA, BUNKYO KU Tokyo 113-0034, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TOGO MEDIKIT CO., LTD. (Owner Number: 8030371)

Owner / Operator Contact Address

17148-6 AZA KAMEKAWA, OAZA HICHIYA, HYUGA CITY, JP-45 883-0062, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172496

PMA Number

N/A

All Registered Proprietary Names

Supercath 5 Supercath5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-02-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-05-07

Official Correspondent

TAKASHI NAKAJIMA

US Agent Details

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

Related Public Records

Same Entity

TOGO MEDIKIT CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014270673	Togo Medikit Co., Ltd. Medikit Hyuga Second Factory	Hyuga City Miyazaki, JP
9612126	TOGO MEDIKIT CO., LTD.	HYUGA CITY Miyazaki, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003184529. Last updated year: 2026. Please use registration number 3003184529 when referencing this establishment in official correspondence.