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HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent - HSA Registration DE0506224

Access comprehensive regulatory information for HANAROSTENT® Esophagus Skidproof (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 DE0506224 and owned by M. I.Tech Co, Ltd. The device was registered on September 27, 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
DE0506224
HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent
HSA Registration Number: DE0506224
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Product Description

This stent is indicated for application in palliative treatment of esophageal stricture and/or trachea- esophageal fistula caused by malignant tumors.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0506224
Registration Date
September 27, 2021
Change Notification Approval Date
January 27, 2023
Retention Due Date
September 26, 2026
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® Esophagus Skidproof (CCC) Fully Covered Stent HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent
Model Identifier(s)
ECD-20-080-070 ECD-20-100-070 ECD-20-120-070 ECD-20-140-070 ECD-20-160-070