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Controller for SmartFlow Compression Sleeve Device

by Cardinal Health 200 LLC United States EUDAMED

Ref 82109Model Controller for SmartFlow Compression Sleeve Device

EMDN Z120607

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number063014000000000000005436X Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Controller for SmartFlow Compression Sleeve Device
Model / Reference
Controller for SmartFlow Compression Sleeve Device, 82109
Primary DI / UDI-DI
10885380186417
Basic UDI-DI
063014000000000000005436X
EMDN Code
Z120607 Pneumatic compression equipment
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000006765
Authorised representative
Cardinal Health Ireland Manufacturing Limited IE-AR-000001988

Other devices from Cardinal Health 200, LLC

See all devices from Cardinal Health 200, LLC →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED 10885380186417|063014000000000000005436X 61 fields · synced 24 Oct 2026