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Single DEHP free bag for platelet storage with sampling bag, one connection tube, 1000 ml

by Meditalia Industriale Srl Italy EUDAMED

Ref 4311019100

EMDN B010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 00054-A Date9 Jul 2026IssuedStatusActive expires 30 May 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00054-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    9 Jul 2026
    Expires
    30 May 2029

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Solutran®hemo Sistemi Accessori
Model / Reference
4311019100
Primary DI / UDI-DI
08058480560196
Basic UDI-DI
805848056PLTR4
EMDN Code
B010202 Platelets concentrate transfer bags and kits
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000032344

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 (1)

  • EUDAMED 93f51bb5-e1c5-43f9-8bb4-923717ac410d 61 fields · synced 22 Oct 2026