Saudi Arabia SFDA registration ME0000000301SFDAA00240
5-Pack, TIP - Passive Catheter Introducer
Saudi Arabia·Medical Device·Medtronic Navigation, Inc.·Class IIIActiveProduct information
Single Use Passive Catheter Introducer Needle
Product use
The Passive Catheter Introducer (PCI) is intended to enable the use of image-guidance for the placement of ventricular catheters and shunts with a StealthStation® system.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000000301SFDAA00240
- Authorization ID
- MDMA-1-2019-0277
- Status
- Active
- Expire Date
- July 08, 2026
Manufacturer
- Manufacturer Name
- Medtronic Navigation, Inc.
Model information
- Model ID(s)
- 9731115
Product accessories
[]
About this record
Access comprehensive regulatory information for 5-Pack, TIP - Passive Catheter Introducer 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 ME0000000301SFDAA00240 and manufactured by Medtronic Navigation, Inc..
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass III