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Coloplast ReTrace® Ureteral Access Sheath - HSA Registration DE0503660

Access comprehensive regulatory information for Coloplast ReTrace® Ureteral Access Sheath in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503660 and owned by Coloplast A/S. The device was registered on September 30, 2019.

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 B
DE0503660
Coloplast ReTrace® Ureteral Access Sheath
HSA Registration Number: DE0503660
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Product Description

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503660
Registration Date
September 30, 2019
Change Notification Approval Date
August 28, 2024
Retention Due Date
September 29, 2025
Product Owner
Short Name
Coloplast A/S
Address
Holtedam 1, 3050 Humlebaek, DENMARK
Registrant
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #15-18, SINGAPORE 079903
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH RETRACE® URETERAL ACCESS SHEATH
Model Identifier(s)
ACXL10 ACXL12 ALXL10 ALXL12 ASXL10 ASXL12 AXXL10 AXXL12