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Performa®

by Merit Medical Systems, Inc. United States EUDAMED

Ref PV515038U1/DModel Performa®

EMDN C010401020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450835944 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Performa Angiography Catheters
Model / Reference
Performa®, PV515038U1/D
Primary DI / UDI-DI
00884450835944
Basic UDI-DI
B-00884450835944
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001366
Authorised representative
Merit Medical Ireland Ltd IE-AR-000001011

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Animal Tissues
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00884450835944|B-00884450835944 61 fields · synced 25 Oct 2026