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CALCUSPLIT - SFDA Registration ME0000003595SFDAA00226

Access comprehensive regulatory information for CALCUSPLIT 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 ME0000003595SFDAA00226 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
ME0000003595SFDAA00226
CALCUSPLIT
SFDA Registration: ME0000003595SFDAA00226
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Product Information

Pneumatic 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
ME0000003595SFDAA00226
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)
27630020
Product Accessories

[{'tradeName': 'CALCUSPLIT Hand Piece', 'description': 'Handle for Pneumatic Lithotripter System', 'gmdn': 'N/A'}, {'tradeName': 'Cleaning Rod', 'description': 'Cleaning Accessory for Pneumatic Lithotripter System ', 'gmdn': 'N/A'}, {'tradeName': 'Tube', 'description': 'Connection Accessory for Pneumatic Lithotripter System ', 'gmdn': 'N/A'}, {'tradeName': 'Supply Tube', 'description': 'Fabric hose for Pneumatic Lithotripter System', 'gmdn': 'N/A'}, {'tradeName': 'Adaptor', 'description': 'Connection Accessory for Pneumatic Lithotripter System', 'gmdn': 'N/A'}, {'tradeName': 'CALCUSPLIT Lithotripsy Probe', 'description': 'Energy transmission accessory for Pneumatic Lithotripter System ', 'gmdn': 'N/A'}]