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HSA · registration DE0510062

MacroLux Medical Technology LoopView® Single-Use Digital Flexible Bronchoscope

SingaporeGastroenterology & UrologyClass BMacroLux Medical Technology Co., Ltd.
Verified
Official record identity
Registration number
DE0510062
Model name
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
B38; B38-C; B38-CG; B38-G; B50; B50-C; B50-CG; B50-G; B58; B58-C; B58-CG; B58-G
Registration date
November 20, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
MacroLux Medical Technology Co., Ltd.
Registrant / registration holder
RADIANCE MEDICAL SYSTEMS
Official 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.

Additional source fields
Product owner address
301, Building 3, NamTai Inno Park In, Guang Ming Avenue, Guangming, 518107 Shenzhen, China
Registrant address
10 BUKIT BATOK CRESCENT, #07-01, THE SPIRE, Singapore 658079
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.