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Singapore HSA registration DE0510062

MacroLux Medical Technology LoopView® Single-Use Digital Flexible Bronchoscope

Singapore flagSingapore·CLASS B·MacroLux Medical Technology Co., Ltd.·Registered November 20, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0510062
Registration Date
November 20, 2024
Retention Due Date
November 19, 2025
Product description
The LoopView® is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. The endoscope is intended to provide visualization via MACROLUX™ video processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
Product Owner
Name
MacroLux Medical Technology Co., Ltd.
Short Name
MacroLux Medical Technology Co., Ltd.
Address
301, Building 3, NamTai Inno Park In, Guang Ming Avenue, Guangming, 518107 Shenzhen, CHINA
Registrant
Name
Radiance Medical Systems
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
Name
Radiance Medical Systems
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model information
Model Name(s)
LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope LoopView® Single-Use Digital Flexible Bronchoscope
Model Identifier(s)
B38 B38-C B38-CG B38-G B50 B50-C B50-CG B50-G B58 B58-C B58-CG B58-G
About this record

Access comprehensive regulatory information for MacroLux Medical Technology LoopView® Single-Use Digital Flexible Bronchoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510062 and owned by MacroLux Medical Technology Co., Ltd.. The device was registered on November 20, 2024.

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 B