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Ultimaster Nagomi

by Terumo Europe N.V. 88 variants

Ref DE-RS4550ASM

Expiring European Union

CE MDR

Valid until

30 Nov 2026

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 Number5413206UMNCE Basic UDI-DI 05413206252046UDI-DIDate26 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20232GB450221124 Expiring Expires in 30 days

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    24 Nov 2022
    Expires
    30 Nov 2026

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Ultimaster Nagomi Sirolimus eluting coronary stent system
Model / Reference
DE-RS4550ASM
Primary DI / UDI-DI
05413206252046
Basic UDI-DI
5413206UMNCE
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