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CALCUSON - SFDA Registration ME0000003595SFDAA00225

Access comprehensive regulatory information for CALCUSON in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000003595SFDAA00225 and manufactured by KARL STORZ SE & Co. KG.

This page provides complete registration details including product category (Medical Device), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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SFDA Official Data
Class IIb
ME0000003595SFDAA00225
CALCUSON
SFDA Registration: ME0000003595SFDAA00225
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Product Information

Ultrasonic Lithotripter System

Product Use

Used to create energy for the destruction of stones during endoscopic urological applications.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000003595SFDAA00225
Authorization ID
MDMA-1-2019-2239
Status
Active
Expire Date
July 16, 2023
Manufacturer
Manufacturer Name
KARL STORZ SE & Co. KG
Model Information
Model ID(s)
27610020
Product Accessories

[{'tradeName': 'Footswitch', 'description': 'Pedal-operated switch for Lithotripter System', 'gmdn': 'N/A'}, {'tradeName': 'Transducer', 'description': 'Transformer for Ultrasonic Lithotripter System', 'gmdn': 'N/A'}, {'tradeName': 'Connecting Cable', 'description': 'Connection Accessory for Ultrasonic Lithotripter System ', 'gmdn': 'N/A'}, {'tradeName': 'Ultrasonic Lithotripsy Probe', 'description': 'Aspiration Probe for Ultrasonic Lithotripter System', 'gmdn': 'N/A'}]