Singapore HSA registration DE0506054

M.I. Tech HANAROSTENT® LowAx™ Colon/Rectum (NNN) Non Covered Stent

Singapore·CLASS C·M. I.Tech Co, Ltd·Registered August 11, 2021

Device classification

Device Class: CLASS C
Medical Speciality Area: Gastroenterology & Urology

Registration information

Registration Number: DE0506054
Registration Date: August 11, 2021
Change Notification Approval Date: January 27, 2023
Retention Due Date: August 10, 2025

Product description

This stent is used for application in palliative treatment of Colon/Rectum stricture caused by malignant tumors.

Product Owner

Name: M. I.Tech Co, Ltd
Short Name: M. I.Tech Co, Ltd
Address: 174, Habuk2-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17706, KOREA, REPUBLIC OF

Registrant

Name: FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address: 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201

Importer

Name: FUJIFILM ASIA PACIFIC PTE LTD FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address: 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201

Model information

Model Name(s): HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent HANAROSTENT® LowAx™ Colon/Rectum (NNN) CNJF Non Covered Stent
Model Identifier(s): CNJF-18-060-230 CNJF-18-070-230 CNJF-18-080-230 CNJF-18-090-230 CNJF-18-100-230 CNJF-18-110-230 CNJF-18-120-230 CNJF-20-060-230 CNJF-20-070-230 CNJF-20-080-230 CNJF-20-090-230 CNJF-20-100-230 CNJF-20-110-230 CNJF-20-120-230 CNJF-22-060-230 CNJF-22-070-230 CNJF-22-080-230 CNJF-22-090-230 CNJF-22-100-230 CNJF-22-110-230 CNJF-22-120-230

About this record

Access comprehensive regulatory information for M.I. Tech HANAROSTENT® LowAx™ Colon/Rectum (NNN) Non Covered Stent in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506054 and owned by M. I.Tech Co, Ltd. The device was registered on August 11, 2021.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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