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M.I.Tech HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage BCF stent with Z-EUS IT™ electrocautery delivery system - HSA Registration DE0506639

Access comprehensive regulatory information for M.I.Tech HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage BCF stent with Z-EUS IT™ electrocautery delivery system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506639 and owned by M. I.Tech Co, Ltd. The device was registered on February 10, 2022.

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
DE0506639
M.I.Tech HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage BCF stent with Z-EUS IT™ electrocautery delivery system
HSA Registration Number: DE0506639
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Product Description

The pancreatic drainage stent with electrocautery delivery system is intended for the drainage of a pancreatic pseudocyst or a gallbladder through a transgastric or transduodenal approach.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0506639
Registration Date
February 10, 2022
Change Notification Approval Date
December 14, 2023
Retention Due Date
February 09, 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® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system HANAROSTENT® HOT Plumber™ with Z-EUS IT™ pancreatic drainage stent with electrocautery delivery system
Model Identifier(s)
BCF-10-020-T140 BCF-10-030-T140 BCF-10-040-T140 BCF-12-020-T140 BCF-12-030-T140 BCF-12-040-T140 BCF-14-020-T140 BCF-14-030-T140 BCF-14-040-T140 BCF-16-020-T140 BCF-16-030-T140 BCF-16-040-T140