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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Ultimaster Tansei Sirolimus eluting… — 54 UDI-DI variants, MDR

MD Atlas
TERUMO EUROPE N.V.

Data from EUDAMED, last updated May 30, 2026

Ultimaster Tansei Sirolimus eluting coronary stent system

5413206UMTCS

54 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class III

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: TERUMO EUROPE N.V.

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Device characteristics

ImplantableIncorporates a medicinal product

Legacy certificates

Certificate number: 13090GB450250128
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: DNV MEDCERT GmbH (0482)
Validity: Jan 28, 2025 → Jan 27, 2030

Identity & classification

Basic UDI-DI: 5413206UMTCS
Device name: Ultimaster Tansei Sirolimus eluting coronary stent system
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: TERUMO EUROPE N.V.
SRN: BE-MF-000001434
Country: Belgium
Email: EUDAMED_TE@terumo-europe.com
Phone: +3216381211

Variants by status

UDI-DI variants

54 UDI-DI variants

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Applied filters

basicUdiUlid01KS4NAS8QKXWSES5VZTZQ1QQ8

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

DE-RQ3012KSM05413206221615
DE-RQ3538KSM05413206221936
DE-RQ3518KSM05413206221837
DE-RQ4038KSM05413206222117
DE-RQ2518KSM05413206220991
DE-RQ2233KSM05413206221158
DE-RQ4015KSM05413206221998
DE-RQ2224KSM05413206221110
DE-RQ4018KSM05413206222018
DE-RQ3009KSM05413206221592
DE-RQ3024KSM05413206221691
DE-RQ4024KSM05413206222056
DE-RQ3018KSM05413206221653
DE-RQ2212KSM05413206221035
DE-RQ4028KSM05413206222070
DE-RQ2509KSM05413206221196
DE-RQ2728KSM05413206221530
DE-RQ2209KSM05413206221011
DE-RQ3524KSM05413206221875
DE-RQ3509KSM05413206221776
DE-RQ3521KSM05413206221851
DE-RQ2521KSM05413206221318
DE-RQ2515KSM05413206220977
DE-RQ3021KSM05413206221677
DE-RQ2712KSM05413206221431

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