Saudi Arabia SFDA registration ME0000000975SFDAA00160
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
Saudi Arabia·MD·Terumo Europe N.V.·Class IIIActiveProduct information
Angiography Catheter
Product use
Radifocus® OptitorqueTM is a sterile and for single use catheter, intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites of the vascular system. It is also used to lead a guide wire or a catheter to the target site.
Device classification
- Risk Class
- Class III
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000000975SFDAA00160
- Authorization ID
- GHTF-2017-1738
- Status
- Active
- Expire Date
- May 26, 2024
Manufacturer
- Manufacturer Name
- Terumo Europe N.V.
Model information
- Model ID(s)
- Refer to the attached letter in 2.1.10
Product accessories
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About this record
Access comprehensive regulatory information for RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER in the Saudi Arabia medical device market through Pure Global AI's free database. This Class III device is registered with Saudi Arabia SFDA under registration number ME0000000975SFDAA00160 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.
Free DatabasePowered by Pure Global AISFDA Official DataClass III