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Scoreflex NC

by OrbusNeich Medical, B.V. 11 variants

Ref 620-154-1Model Ø 2.0 x 15 mm

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08719244950041 Basic UDI-DI 08719244950041UDI-DIDate5 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

NorwaySwedenFinlandLatviaLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeGreeceCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 24 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 1 Feb 2017
  • Belgium since 1 Jan 2017
  • Bulgaria since 1 Feb 2018
  • Cyprus since 1 Mar 2017
  • Czechia since 1 Jan 2017
  • Finland since 1 Jan 2018
  • France since 1 Jan 2017
  • Germany since 26 Oct 2016
  • Greece since 1 Feb 2020
  • Hungary since 1 May 2017
  • Ireland since 24 Aug 2018
  • Italy since 26 Oct 2016
  • Latvia since 1 Apr 2019
  • Lithuania since 25 Jul 2019
  • Netherlands since 16 Nov 2016
  • Norway since 6 Oct 2017
  • Poland since 30 Aug 2017
  • Portugal since 1 Jun 2020
  • Romania since 1 Sep 2017
  • Slovakia since 1 Jan 2017
  • Slovenia since 24 Nov 2017
  • Spain since 1 Jan 2018
  • Sweden since 29 Nov 2017
  • Türkiye since 4 Oct 2019

Last checked 29 Oct 2026.

Specification

EUDAMED

Model / Reference
Ø 2.0 x 15 mm, 620-154-1
Primary DI / UDI-DI
08719244950041
Basic UDI-DI
B-08719244950041
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
NL-MF-000010907

Other devices from OrbusNeich Medical, B.V.

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Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No