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Aperto Otw

by Cardionovum GmbH 23 variants

Ref APL9.00-40 OTW

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05906190157768 Basic UDI-DI 05906190157768UDI-DIDate16 Oct 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  • Withdrawn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 20 Dec 2013
  • Belgium since 20 Dec 2013
  • Bulgaria since 20 Dec 2013
  • Croatia since 20 Dec 2013
  • Cyprus since 20 Dec 2013
  • Czechia since 20 Dec 2013
  • Denmark since 20 Dec 2013
  • Estonia since 20 Dec 2013
  • Finland since 20 Dec 2013
  • France since 20 Dec 2013
  • Germany since 20 Dec 2013
  • Greece since 20 Dec 2013
  • Hungary since 20 Dec 2013
  • Iceland since 20 Dec 2013
  • Ireland since 20 Dec 2013
  • Italy since 20 Dec 2013
  • Latvia since 20 Dec 2013
  • Liechtenstein since 20 Dec 2013
  • Lithuania since 20 Dec 2013
  • Luxembourg since 20 Dec 2013
  • Malta since 20 Dec 2013
  • Netherlands since 20 Dec 2013
  • Northern Ireland since 20 Dec 2013
  • Norway since 20 Dec 2013
  • Poland since 20 Dec 2013
  • Portugal since 20 Dec 2013
  • Romania since 20 Dec 2013
  • Slovakia since 20 Dec 2013
  • Slovenia since 20 Dec 2013
  • Spain since 20 Dec 2013
  • Sweden since 20 Dec 2013
  • Türkiye since 20 Dec 2013

Last checked 23 Oct 2026.

Specification

EUDAMED

Device Name
Aperto Otw Paclitaxel Releasing Hemodialysis Shunt Balloon Dilatation Catheter
Model / Reference
APL9.00-40 OTW
Primary DI / UDI-DI
05906190157768
Basic UDI-DI
B-05906190157768
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class III
EU market of registration
Germany

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