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Ultraverse

by Bard Peripheral Vascular, Inc. 542 variants

Part of a family of 841 devices: see the family page

Ref U8100615

Ultraverse (U8100615) is a Class IIa device made by Bard Peripheral Vascular, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 0801741OVDRDUTB5M), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0801741OVDRDUTB5M Basic UDI-DI 00801741164767UDI-DIDate20 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Ultraverse™ 014 & 018 PTA Balloon Dilatation Catheter
Model / reference
U8100615
Primary DI / UDI-DI
00801741164767
Basic UDI-DI
0801741OVDRDUTB5M
EMDN code
C010402020101 PTA balloon dilatation catheters
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

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

Similar devices in this category

Other devices filed under PTA BALLOON DILATATION CATHETERS.

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties

  • Supplied sterile
Other properties (13, all answered No)