Skip to content

Dialysis Kit

by ITL Asia Pacific Sdn. Bhd. Malaysia EUDAMED

Ref 061PC05014A

EMDN F0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955524040DP1SEF Basic UDI-DIDate31 Jul 2023RegisteredStatusActive

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
061PC05014A
Primary DI / UDI-DI
09555240403827, 09555240407153
Basic UDI-DI
955524040DP1SEF, 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-MF-000001570
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Itl Asia Pacific Sdn. Bhd.

See all devices from Itl Asia Pacific Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 (2)

  • EUDAMED 462ba313-bf8f-4900-a6d9-32fb8ed7f744 61 fields · synced 22 Oct 2026
  • EUDAMED 7f779e93-0eff-4690-bc3e-2ad1ba1b1361 61 fields · synced 16 Jul 2026