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Controller for SmartFlow Compression Sleeve Device

by Cardinal Health 200 LLC

Ref 82105Model Controller for SmartFlow Compression Sleeve Device

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000005436X Basic UDI-DI 10885380185120UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10885380185120 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Kendall
Generic Name
Intermittent venous compression system
Device Name
Controller for SmartFlow Compression Sleeve Device
Model / Ref / Catalog
Controller for SmartFlow Compression Sleeve Device, 82105
Primary DI / UDI-DI
10885380185120
Basic UDI-DI
063014000000000000005436X
FDA Product Code
JOW
EMDN Code
Z120607 Pneumatic compression equipment
GMDN Term
Intermittent venous compression system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.5800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No