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Ultimaster Tansei

by Terumo Europe N.V. 54 variants

Ref DE-RQ3533KSM

Active European Union

CE MDR

Valid until

27 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5413206UMTCS Basic UDI-DI 05413206221912UDI-DIDate21 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13090GB450250128 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    28 Jan 2025
    Expires
    27 Jan 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ultimaster Tansei Sirolimus eluting coronary stent system
Model / Reference
DE-RQ3533KSM
Primary DI / UDI-DI
05413206221912
Basic UDI-DI
5413206UMTCS
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001434

Other devices from Terumo Europe N.V.

See all devices from Terumo Europe N.V. →

Properties

  • Sterile
  • Implantable
  • CMR Substance
  • Incorporates Medicinal Product

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No