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Singapore HSA registration DE0502619

Terumo Ultimaster Tansei Sirolimus Eluting Coronary Stent System

Singapore flagSingapore·CLASS COM·TERUMO EUROPE N.V.·Registered December 27, 2018
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0502619
Registration Date
December 27, 2018
Change Notification Approval Date
May 03, 2023
Retention Due Date
December 26, 2025
Product description
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.
Product Owner
Name
TERUMO EUROPE N.V.
Short Name
TERUMO EUROPE N.V.
Address
Interleuvenlaan 40, 3001 Leuven, BELGIUM
Registrant
Name
TERUMO ASIA HOLDINGS PTE LTD
Address
300 BEACH ROAD, THE CONCOURSE, #37-01, SINGAPORE 199555
Importer
Name
TERUMO ASIA HOLDINGS PTE LTD TERUMO SINGAPORE PTE LTD
Address
300 BEACH ROAD, CONCOURSE, THE, #37-01, SINGAPORE 199555 300 BEACH ROAD, CONCOURSE, THE, #33-06, SINGAPORE 199555
Model information
Model Name(s)
Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent Ultimaster Tansei sirolimus eluting coronary stent
Model Identifier(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
About this record

Access comprehensive regulatory information for Terumo Ultimaster Tansei Sirolimus Eluting Coronary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0502619 and owned by TERUMO EUROPE N.V.. The device was registered on December 27, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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