Skip to content

Aperta NSE PTA Balloon Dilatation Catheter

by Nipro Vascular Corporation EUDAMED

Active European Union

Ref AA18-09060040Model Balloon length 40mm x Catheter length 50cm, 90cm, 145cm

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4543660GMW172A100000000YC Basic UDI-DIDate9 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Balloon length 40mm x Catheter length 50cm, 90cm, 145cm, AA18-09060040
Primary DI / UDI-DI
04543660025663
Basic UDI-DI
4543660GMW172A100000000YC
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000001989
Authorised representative
Nipro Vascular Ireland Ltd IE-AR-000000771

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from Nipro Vascular Corporation

See all devices from Nipro Vascular Corporation →

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