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IMPACT APC Set

by Plasmaconcept AG EUDAMED

Active European Union

Ref 210011Model IMPACT Set with anti-coagulant

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426053139IMP210011E4 Basic UDI-DIDate18 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
IMPACT Set
Model / Reference
IMPACT Set with anti-coagulant, 210011
Primary DI / UDI-DI
04260531390117
Basic UDI-DI
426053139IMP210011E4
EMDN Code
B0480 Autotransfusion devices - accessories
Device Class
Class IIb
Medical Purpose
IMPACT set for producing autologous blood derivatives with the IMPACT system. Reinjection of autologous blood derivatives.

Manufacturer details

EUDAMED SRN
DE-PR-000020235

Other devices from Plasmaconcept AG

Properties

Other properties (1)

  • Sterile: No