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Foot Cuffs for SmartFlow Compression Device

by Cardinal Health 200 LLC

Ref 83032Model Foot Cuffs for SmartFlow Compression Device

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0630140000000000000054573 Basic UDI-DI 10885380186370UDI-DIDate9 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Foot Cuffs for SmartFlow Compression Device
Model / Reference
Foot Cuffs for SmartFlow Compression Device, 83032
Primary DI / UDI-DI
10885380186370
Basic UDI-DI
0630140000000000000054573
EMDN Code
Z120607 Pneumatic compression equipment
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

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

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Properties

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