Pure Global
Singapore HSA registration DE0506168

M.I.Tech HANAROSTENT® Biliary (CCC) Fully Covered Stent

Singapore flagSingapore·CLASS C·M. I.Tech Co, Ltd·Registered September 13, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0506168
Registration Date
September 13, 2021
Change Notification Approval Date
January 27, 2023
Retention Due Date
September 12, 2025
Product description
This stent is used for application in palliative treatment of bile duct 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® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent HANAROSTENT® Biliary (CCC) Fully Covered Stent
Model Identifier(s)
BCL-08-040-180 BCL-08-050-180 BCL-08-060-180 BCL-08-070-180 BCL-08-080-180 BCL-08-090-180 BCL-08-100-180 BCL-10-040-180 BCL-10-050-180 BCL-10-060-180 BCL-10-070-180 BCL-10-080-180 BCL-10-090-180 BCL-10-100-180
About this record

Access comprehensive regulatory information for M.I.Tech HANAROSTENT® Biliary (CCC) Fully 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 DE0506168 and owned by M. I.Tech Co, Ltd. The device was registered on September 13, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C