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LEO+ Intracranial stelf- expandable stent

by Balt extrusion SAS 26 variants

Ref LEO.4,0X35

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-03700481330258 Basic UDI-DI 03700481330258UDI-DIDate5 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  • Withdrawn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 18 Jun 2007
  • Belgium since 18 Jun 2007
  • Bulgaria since 18 Jun 2007
  • Croatia since 18 Jun 2007
  • Cyprus since 18 Jun 2007
  • Czechia since 18 Jun 2007
  • Denmark since 18 Jun 2007
  • Estonia since 18 Jun 2007
  • Finland since 18 Jun 2007
  • France since 18 Jun 2007
  • Germany since 18 Jun 2007
  • Greece since 18 Jun 2007
  • Hungary since 18 Jun 2007
  • Iceland since 18 Jun 2007
  • Ireland since 18 Jun 2007
  • Italy since 18 Jun 2007
  • Latvia since 18 Jun 2007
  • Liechtenstein since 18 Jun 2007
  • Lithuania since 18 Jun 2007
  • Luxembourg since 18 Jun 2007
  • Malta since 18 Jun 2007
  • Netherlands since 18 Jun 2007
  • Northern Ireland since 18 Jun 2007
  • Norway since 18 Jun 2007
  • Poland since 18 Jun 2007
  • Portugal since 18 Jun 2007
  • Romania since 18 Jun 2007
  • Slovakia since 18 Jun 2007
  • Slovenia since 18 Jun 2007
  • Spain since 18 Jun 2007
  • Sweden since 18 Jun 2007
  • Türkiye since 18 Jun 2007

Last checked 27 Oct 2026.

Specification

EUDAMED

Device Name
LEO+ Intracranial stelf- expandable stent
Model / Reference
LEO.4, 0X35
Primary DI / UDI-DI
03700481330258
Basic UDI-DI
B-03700481330258
EMDN Code
P070402020102 Non-stainless steel peripheral vascular bare metal stents
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000007563

From the manufacturer

Manufacturer's product page: LEO+ Self-Expandable Braided Stent

Other devices from Balt extrusion SAS

See all devices from Balt extrusion SAS →

Properties

  • Sterile
  • Implantable

Other properties (11)

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