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CRISTAL BALLOON angioplasty catheter

by Balt extrusion SAS 31 variants

Ref CBV28X50/110

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03700481332016 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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
CRISTAL BALLOON angioplasty catheter
Model / Reference
CBV28X50/110
Primary DI / UDI-DI
03700481332016, 03700481332023
Basic UDI-DI
B-03700481332016, B-03700481332023
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