Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014270673

FEI Number

3014270673

Entity Name

Togo Medikit Co., Ltd. Medikit Hyuga Second Factory

City/State/Country

Hyuga City Miyazaki, JP

Establishment Address

435-3, Hei, Aza Kakinokida, Yamage, Togo-cho,, Hyuga City Miyazaki 883-0102, JP

Establishment Type(s)

Manufacture Medical 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

K190001

PMA Number

N/A

All Registered Proprietary Names

Supercath 5

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

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
9612126	TOGO MEDIKIT CO., LTD.	HYUGA CITY Miyazaki, JP
3003184529	MEDIKIT CO., LTD.	BUNKYO KU Tokyo, 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014270673. Last updated year: 2026. Please use registration number 3014270673 when referencing this establishment in official correspondence.