Singapore HSA registration DE0503660
Coloplast ReTrace® Ureteral Access Sheath
Singapore·CLASS B·Coloplast A/S·Registered September 30, 2019Device 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 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.
Product Owner
- Name
- Coloplast A/S
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B