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RADIFOCUS Introducer II - SFDA Registration ME0000000975SFDAA00157

Access comprehensive regulatory information for RADIFOCUS Introducer II in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000000975SFDAA00157 and manufactured by Terumo Europe N.V..

This page provides complete registration details including product category (MD), 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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Class IIa
ME0000000975SFDAA00157
RADIFOCUS Introducer II
SFDA Registration: ME0000000975SFDAA00157
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Product Information

Catheter introducing sheath

Product Use

The Radifocus Introducer II Transradial kit is sterile and for single use and is intended to be inserted percutaneously into the radial artery to facilitate the insertion of angiographic, electrode, balloon, or similar catheters.

Device Classification
Risk Class
Class IIa
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000000975SFDAA00157
Authorization ID
GHTF-2016-1513
Status
Active
Expire Date
October 11, 2023
Manufacturer
Manufacturer Name
Terumo Europe N.V.
Model Information
Model ID(s)
RT-R40A07PQ RT-R40A10PQ RT-R40D07PQ RT-R40D10PQ RT-R40G07PQ RT-R40G10PQ RT-R50A07PQ RT-R50A10PQ RT-R50D10PQ RT-R50G07PQ RT-R50G10PQ RT-R60A07PQ RT-R60A10PQ RT-R60D10PQ RT-R60G07PQ RT-R60G10PQ RT-R70D10PQ
Product Accessories

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