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Dialysis Kit

by ITL Asia Pacific Sdn. Bhd. Malaysia EUDAMED

Ref 061PC05016A

EMDN F0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955524040DPSNE Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dialysis Pack
Model / Reference
061PC05016A
Primary DI / UDI-DI
09555240407207
Basic UDI-DI
955524040DPSNE
EMDN Code
F0399 Dialysis kits - other
Device Class
Class I
Medical Purpose
The procedure pack provides the necessary items, which are mutually compatible for skin prep prior to the commencement of haemodialysis.

Manufacturer details

EUDAMED SRN
MY-PR-000045529

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 5ac86ff2-b0f5-44af-b698-32a0b7c5fbe7 61 fields · synced 22 Oct 2026