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Approachยฎ Hydro ST - SFDA Registration ME0000006512SFDAA01286

Access comprehensive regulatory information for Approachยฎ 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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SFDA Official Data
Class IIa
ME0000006512SFDAA01286
Approachยฎ Hydro ST
SFDA Registration: ME0000006512SFDAA01286
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Product 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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