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Performa®

by Merit Medical Systems, Inc. 10 variants

Ref RADMPP-10/DModel Performa®

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10884450459123 Basic UDI-DI 10884450459123UDI-DIDate9 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Performa Angiography Catheters
Model / Reference
Performa®, RADMPP-10/D
Primary DI / UDI-DI
10884450459123
Basic UDI-DI
B-10884450459123
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Austria

Manufacturer details

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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • 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