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LEO+Baby Intracranial self-expandable stent

by Balt extrusion SAS 12 variants

Ref LEO.2,5X35

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-03700481334959 Basic UDI-DI 03700481334959UDI-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  • Withdrawn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 4 May 2012
  • Belgium since 4 May 2012
  • Bulgaria since 4 May 2012
  • Croatia since 4 May 2012
  • Cyprus since 4 May 2012
  • Czechia since 4 May 2012
  • Denmark since 4 May 2012
  • Estonia since 4 May 2012
  • Finland since 4 May 2012
  • France since 4 May 2012
  • Germany since 4 May 2012
  • Greece since 4 May 2012
  • Hungary since 4 May 2012
  • Iceland since 4 May 2012
  • Ireland since 4 May 2012
  • Italy since 4 May 2012
  • Latvia since 4 May 2012
  • Liechtenstein since 4 May 2012
  • Lithuania since 4 May 2012
  • Luxembourg since 4 May 2012
  • Malta since 4 May 2012
  • Netherlands since 4 May 2012
  • Northern Ireland since 4 May 2012
  • Norway since 4 May 2012
  • Poland since 4 May 2012
  • Portugal since 4 May 2012
  • Romania since 4 May 2012
  • Slovakia since 4 May 2012
  • Slovenia since 4 May 2012
  • Spain since 4 May 2012
  • Sweden since 4 May 2012
  • Türkiye since 4 May 2012

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
LEO+Baby Intracranial self-expandable stent
Model / Reference
LEO.2, 5X35
Primary DI / UDI-DI
03700481334959
Basic UDI-DI
B-03700481334959
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