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Solutran®hemo Bionest 12B

by Meditalia Industriale Srl Italy EUDAMED

Ref 4911001900 EMDN B019003

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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 24 Oct 2026

Device Name
Solutran®hemo Bionest system for adult donor platet lysate
Model / Reference
4911001900
Primary DI / UDI-DI
08058480560035
Basic UDI-DI
805848056CPWC
EMDN Code
B019003 Blood components aliquotation kits
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000032344

Other devices from Meditalia Industriale Srl

See all devices from Meditalia Industriale Srl →

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 b0654f77-be8f-4498-9cdb-f31e85710913 61 fields · synced 24 Oct 2026