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M.I.Tech HANAROSTENT® Biliary (CCC) Fully Covered Stent - HSA Registration DE0506168

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.

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CLASS C
DE0506168
M.I.Tech HANAROSTENT® Biliary (CCC) Fully Covered Stent
HSA Registration Number: DE0506168
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Product Description

This stent is used for application in palliative treatment of bile duct stricture caused by malignant tumors.

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 Owner
Short Name
M. I.Tech Co, Ltd
Address
174, Habuk2-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17706, KOREA, REPUBLIC OF
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
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