Ultimaster Tansei Sirolimus Eluting Coronary Stent System - SFDA Registration ME0000000975SFDAA00158

Access comprehensive regulatory information for Ultimaster Tansei Sirolimus Eluting Coronary Stent System 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 ME0000000975SFDAA00158 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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SFDA Official Data

Class III

ME0000000975SFDAA00158

Ultimaster Tansei Sirolimus Eluting Coronary Stent System

SFDA Registration: ME0000000975SFDAA00158

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Product Information

Sirolimus eluting coronary stent system

Product Use

Ultimaster Tansei Sirolimus Eluting Coronary Stent System is indicated for improving myocardial blood flow in patients with stenotic lesions in coronary arteries, including but not limited to patients with STEMI, NSTEMI, acute coronary syndrome, diabetes mellitus, multivessel disease, bifurcation lesions, patients older than 65 years, male and female patients, patients with totally occluded lesions, long lesions, lesions residing in small coronary vessels, restenotic lesions including in-stent restenosis, ostial lesions, lesions in left main coronary artery. The Ultimaster Tansei stent system is suitable for both femoral and radial approach.

Device Classification

Risk Class

Class III

Product Category

Product Type

Registration Information

Registration ID

ME0000000975SFDAA00158

Authorization ID

GHTF-2018-1938

Status

Active

Expire Date

May 27, 2024

Manufacturer

Manufacturer Name

Terumo Europe N.V.

Model Information

Model ID(s)

DE-RQ2209KSM, DE-RQ2212KSM, DE-RQ2215KSM, DE-RQ2218KSM, DE-RQ2221KSM, DE-RQ2224KSM, DE-RQ2228KSM, DE-RQ2233KSM, DE-RQ2238KSM, DE-RQ2509KSM, DE-RQ2512KSM, DE-RQ2515KSM, DE-RQ2518KSM, DE-RQ2521KSM, DE-RQ2524KSM, DE-RQ2528KSM, DE-RQ2533KSM, DE-RQ2538KSM, DE-RQ2709KSM, DE-RQ2712KSM, DE-RQ2715KSM, DE-RQ2718KSM, DE-RQ2721KSM, DE-RQ2724KSM, DE-RQ2728KSM, DE-RQ2733KSM, DE-RQ2738KSM, DE-RQ3009KSM, DE-RQ3012KSM, DE-RQ3015KSM, DE-RQ3018KSM, DE-RQ3021KSM, DE-RQ3024KSM, DE-RQ3028KSM, DE-RQ3033KSM, DE-RQ3038KSM, DE-RQ3509KSM, DE-RQ3512KSM, DE-RQ3515KSM, DE-RQ3518KSM, DE-RQ3521KSM, DE-RQ3524KSM, DE-RQ3528KSM, DE-RQ3533KSM, DE-RQ3538KSM, DE-RQ4009KSM, DE-RQ4012KSM, DE-RQ4015KSM, DE-RQ4018KSM, DE-RQ4021KSM, DE-RQ4024KSM, DE-RQ4028KSM, DE-RQ4033KSM, DE-RQ4038KSM

Product Accessories

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