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Singapore HSA registration DE0507108

STORZ MEDICAL MODULITH® SLX-F2

Singapore flagSingapore·CLASS C·Storz Medical AG·Registered July 25, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0507108
Registration Date
July 25, 2022
Change Notification Approval Date
June 28, 2023
Retention Due Date
July 24, 2025
Product description
The MODULITH® SLX-F2 system offers a modular and multifunctional stationary urological X-ray workstation with an integrated shock wave unit (lithotripter) and optional remote control functionality. It is intended for the use in clinical, semi-sterile surgery environments for endourological and percutaneous procedures (such as URS or PCNL) as well as lithotripsy treatment. The system is suitable for X-ray examinations on children aged between 3 and 22 years old. The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over. The patient table is designed to support patient positioning during endourological or other minimally invasive urological interventions.
Product Owner
Name
Storz Medical AG
Short Name
Storz Medical AG
Address
Lohstampfestraβe 8, 8274 Tägerwilen, SWITZERLAND
Registrant
Name
KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.
Address
8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Importer
Name
KARL STORZ ENDOSCOPY ASIA MARKETING PTE. LTD. KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #03-02, SINGAPORE 149555 8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Model information
Model Name(s)
C-MX MODULITH® SLX-F2 MX/1000 FP21 XR-MX/1000
Model Identifier(s)
C-MX MODULITH® SLX-F2 MX/1000 FP21 XR-MX/1000
About this record

Access comprehensive regulatory information for STORZ MEDICAL MODULITH® SLX-F2 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507108 and owned by Storz Medical AG. The device was registered on July 25, 2022.

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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