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Singapore HSA registration DE0509770

MacroLux CoralView® Single-Use Digital Flexible Ureteroscope

Singapore flagSingapore·CLASS B·MacroLux Medical Technology Co., Ltd·Registered September 11, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0509770
Registration Date
September 11, 2024
Retention Due Date
September 10, 2025
Product description
The CoralView® Single-Use Digital Flexible Ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
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
QST TECHNOLOGIES PTE. LTD.
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Name
QST DENTAL PTE. LTD. QST TECHNOLOGIES PTE. LTD.
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model information
Model Name(s)
CoralView® Single-Use Digital Flexible Ureteroscope CoralView® Single-Use Digital Flexible Ureteroscope CoralView® Single-Use Digital Flexible Ureteroscope CoralView® Single-Use Digital Flexible Ureteroscope CoralView® Single-Use Digital Flexible Ureteroscope CoralView® Single-Use Digital Flexible Ureteroscope
Model Identifier(s)
U10 U10-B U10-BR U20 U20-B U20-BR
About this record

Access comprehensive regulatory information for MacroLux CoralView® Single-Use Digital Flexible Ureteroscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509770 and owned by MacroLux Medical Technology Co., Ltd. The device was registered on September 11, 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