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CRISTAL BALLOON angioplasty catheter

by Balt extrusion SAS 31 variants

Ref CBV20X45/110

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03700481331873 Basic UDI-DI Date5 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  • Withdrawn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 Mar 1998
  • Belgium since 4 Mar 1998
  • Bulgaria since 4 Mar 1998
  • Croatia since 4 Mar 1998
  • Cyprus since 4 Mar 1998
  • Czechia since 4 Mar 1998
  • Denmark since 4 Mar 1998
  • Estonia since 4 Mar 1998
  • Finland since 4 Mar 1998
  • France since 4 Mar 1998
  • Germany since 4 Mar 1998
  • Greece since 4 Mar 1998
  • Hungary since 4 Mar 1998
  • Iceland since 4 Mar 1998
  • Ireland since 4 Mar 1998
  • Italy since 4 Mar 1998
  • Latvia since 4 Mar 1998
  • Liechtenstein since 4 Mar 1998
  • Lithuania since 4 Mar 1998
  • Luxembourg since 4 Mar 1998
  • Malta since 4 Mar 1998
  • Netherlands since 4 Mar 1998
  • Northern Ireland since 4 Mar 1998
  • Norway since 4 Mar 1998
  • Poland since 4 Mar 1998
  • Portugal since 4 Mar 1998
  • Romania since 4 Mar 1998
  • Slovakia since 4 Mar 1998
  • Slovenia since 4 Mar 1998
  • Spain since 4 Mar 1998
  • Sweden since 4 Mar 1998
  • Türkiye since 4 Mar 1998

Last checked 24 Oct 2026.

Specification

EUDAMED

Device Name
CRISTAL BALLOON angioplasty catheter
Model / Reference
CBV20X45/110
Primary DI / UDI-DI
03700481331873, 03700481331880
Basic UDI-DI
B-03700481331873, B-03700481331880
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000007563

From the manufacturer

Manufacturer's product page: Eclipse 2L Double Lumen Balloon Catheter

Other devices from Balt extrusion SAS

See all devices from Balt extrusion SAS →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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