Saudi Arabia SFDA registration ME0000006512SFDAA01286
Approach® Hydro ST
Saudi Arabia·MD·Cook Incorporated·Class IIaActiveProduct information
Approach Hydro ST incorporates a stainless steel shaft with distal stainless steel and platinum coils and a hydrophilic floppy tip, used for general peripheral vascular interventions.
Product use
intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Device classification
- Risk Class
- Class IIa
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000006512SFDAA01286
- Authorization ID
- GHTF-2020-1519
- Status
- Active
- Expire Date
- July 17, 2023
Manufacturer
- Manufacturer Name
- Cook Incorporated
Model information
- Model ID(s)
- HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Product accessories
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About this record
Access comprehensive regulatory information for Approach® Hydro ST 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 ME0000006512SFDAA01286 and manufactured by Cook Incorporated.
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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