Saudi Arabia SFDA registration ME0000000975SFDAA00158
Ultimaster Tansei Sirolimus Eluting Coronary Stent System
Saudi Arabia·MD·Terumo Europe N.V.·Class IIIActiveProduct 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
- MD
- Product Type
- MD
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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About this record
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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