Skip to content

Ultrascore

by Bard Peripheral Vascular, Inc. United States EUDAMED

Ref US35575720

EMDN C010402020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0801741VLNHFHPW4F Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
ULtraScore Focused Force PTA Balloon
Model / Reference
US35575720
Primary DI / UDI-DI
00801741117534
Basic UDI-DI
0801741VLNHFHPW4F
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000017556
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00801741117534|0801741VLNHFHPW4F 61 fields · synced 25 Oct 2026