Singapore HSA registration DE0506224
HANAROSTENT® Esophagus Skidproof (CCC) Fully Covered Stent
Singapore·CLASS C·M. I.Tech Co, Ltd·Registered September 27, 2021Device 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 description
This stent is indicated for application in palliative treatment of esophageal stricture and/or trachea- esophageal fistula caused by malignant tumors.
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
About this record
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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