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Lacrosse NSE ALPHA Coronary Dilatation Catheter

by Nipro Vascular Corporation EUDAMED

Active European Union

Ref NSA20013

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4543660GMW1403100000000F6 Basic UDI-DIDate16 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 756384 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    28 Jul 2026
    Expires
    16 Nov 2028
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
NSA20013
Primary DI / UDI-DI
04543660019969
Basic UDI-DI
4543660GMW1403100000000F6
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

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

Other devices from Nipro Vascular Corporation

See all devices from Nipro Vascular Corporation →

Properties

  • Sterile
  • CMR Substance
  • Animal Tissues

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No