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SELUTION SLR™ 04 PTCA Balloon Catheter

by MedAlliance CardioVascular SA

Ref SC14-500035

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-07640278882835 Basic UDI-DI 07640278882835UDI-DIDate13 Jul 2026RegisteredStatusActive

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

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

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

  • Austria since 11 Mar 2022
  • Belgium since 1 Jan 2025
  • Bulgaria since 22 Apr 2022
  • Croatia since 23 Jul 2021
  • Cyprus since 2 May 2022
  • Czechia since 1 Jul 2025
  • Denmark
  • Estonia
  • Finland since 23 Mar 2021
  • France since 1 May 2022
  • Germany since 2 Mar 2021
  • Greece since 24 Dec 2020
  • Hungary since 13 Jul 2021
  • Iceland
  • Ireland since 26 Feb 2021
  • Italy since 8 Oct 2020
  • Latvia since 1 Mar 2024
  • Liechtenstein
  • Lithuania since 15 Nov 2022
  • Luxembourg since 1 Mar 2026
  • Malta
  • Netherlands since 4 Feb 2021
  • Northern Ireland since 1 Jan 2025
  • Norway
  • Poland since 1 Jul 2021
  • Portugal since 1 Mar 2023
  • Romania since 23 Feb 2021
  • Slovakia since 28 May 2021
  • Slovenia since 30 Sep 2022
  • Spain since 1 Mar 2022
  • Sweden
  • Türkiye since 9 Apr 2021

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
SELUTION SLR™ PTCA Balloon Catheter
Model / Reference
SC14-500035
Primary DI / UDI-DI
07640278882835
Basic UDI-DI
B-07640278882835
EMDN Code
C010401020199 Ptca dilatation catheters - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000025421
Authorised representative
MedAlliance Germany GmbH DE-AR-000023728

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Properties

  • Sterile
  • Incorporates Medicinal Product

Other properties (9)

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