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Restore Deb

by Cardionovum GmbH 27 variants

Ref R 2.50-25

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-05906190156112 Basic UDI-DI 05906190156112UDI-DIDate5 Aug 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  • Withdrawn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 31 May 2019
  • Belgium since 31 May 2019
  • Bulgaria since 31 May 2019
  • Croatia since 31 May 2019
  • Cyprus since 31 May 2019
  • Czechia since 31 May 2019
  • Denmark since 31 May 2019
  • Estonia since 31 May 2019
  • Finland since 31 May 2019
  • France since 31 May 2019
  • Germany since 31 May 2019
  • Greece since 31 May 2019
  • Hungary since 31 May 2019
  • Iceland since 31 May 2019
  • Ireland since 31 May 2019
  • Italy since 31 May 2019
  • Latvia since 31 May 2019
  • Liechtenstein since 31 May 2019
  • Lithuania since 31 May 2019
  • Luxembourg since 31 May 2019
  • Malta since 31 May 2019
  • Netherlands since 31 May 2019
  • Northern Ireland since 31 May 2019
  • Norway since 31 May 2019
  • Poland since 31 May 2019
  • Portugal since 31 May 2019
  • Romania since 31 May 2019
  • Slovakia since 31 May 2019
  • Slovenia since 31 May 2019
  • Spain since 31 May 2019
  • Sweden since 31 May 2019
  • Türkiye since 31 May 2019

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter
Model / Reference
R 2.50-25
Primary DI / UDI-DI
05906190156112
Basic UDI-DI
B-05906190156112
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
DE-MF-000005316

Other devices from Cardionovum GmbH

See all devices from Cardionovum GmbH →

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