HSA · registration MDPR251031W0003

CoralWell Single-use Ureteral Access Sheath

Name: CoralWell Single-use Ureteral Access Sheath — HSA MDPR251031W0003
Creator: MacroLux Medical Technology Co., Ltd
Keywords: CoralWell Single-use Ureteral Access Sheath, CoralWell Single-use Ureteral Access Sheath, MDPR251031W0003, Gastroenterology & Urology, HSA

SingaporeGastroenterology & UrologyClass BMacroLux Medical Technology Co., Ltd

Verified

Official record identity

Registration number: MDPR251031W0003
Model name: Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath; Single-use Ureteral Access Sheath
Model identifier: NS-0835B; NS-0840B; NS-0845B; NS-0855B; NS-0935B; NS-0940B; NS-0945B; NS-0955B; NS-1035B; NS-1040B; NS-1045B; NS-1055B; NS-1135B; NS-1140B; NS-1145B; NS-1155B; NS-1235B; NS-1240B; NS-1245B; NS-1255B; NS-1335B; NS-1340B; NS-1345B; NS-1355B; NS-1435B; NS-1440B; NS-1445B; NS-1455B
Registration date: October 31, 2025
Source update date: April 23, 2026

Classification

Risk class: Class B
Published category: Gastroenterology & Urology

Published parties

Product owner: MacroLux Medical Technology Co., Ltd
Registrant / registration holder: QST TECHNOLOGIES PTE. LTD.

Official description

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Additional source fields

Product owner address: 301, Building 3, NamTai Inno Park In Guang Ming, Avenue Guangming, 518107 Shenzhen, China
Registrant address: 196 PANDAN LOOP, #04-29, PANTECH BUSINESS HUB, Singapore 128384

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.