TOGO MEDIKIT CO., LTD.

FDA Device Registration & Listing · HYUGA CITY Miyazaki, JP · Registration 9612126

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612126
FEI Number
3002807548
Entity Name
TOGO MEDIKIT CO., LTD.
City/State/Country
HYUGA CITY Miyazaki, JP
Establishment Address
17148-6 AZA KAMEKAWA, OAZA HICHIYA, HYUGA CITY Miyazaki 883-0062, JP
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Set SUPER SHEATH XL INTRODUCER SHEATH Mongoose Angiographic Catheter Super Sheath R/O Super Sheath Super Sheath, Super Sheath R/O Supercath 5 Supercath5 Supercath5 Super Sheath CBDE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-12-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2006-04-26
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-12-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2020-10-29
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2015-09-16
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-09-16
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
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-09-12
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2021-04-05

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
3003184529 MEDIKIT CO., LTD. BUNKYO KU Tokyo, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612126. Last updated year: 2026. Please use registration number 9612126 when referencing this establishment in official correspondence.
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