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RADIFOCUS Optitorque – Angiographic catheter

by Terumo Europe N.V.

Ref RH-6JR6000M

Active European Union

CE MDR

Valid until

13 Apr 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products 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 Number5413206OPTIRHV8 Basic UDI-DI 05413206031269UDI-DIDate5 Oct 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
RH-6JR6000M
Primary DI / UDI-DI
05413206031269
Basic UDI-DI
5413206OPTIRHV8
EMDN Code
C0104010101, C0104010202, C0104020101, C0104020204
Device Class
Class III

Manufacturer details

EUDAMED SRN
BE-MF-000001434

Other devices from Terumo Europe N.V.

See all devices from Terumo Europe N.V. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No