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Solutran®hemo BioNest SAG-M Bag

by Meditalia Industriale Srl Italy EUDAMED

Ref 710000S000

EMDN B010201

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

Model / Reference
710000S000
Primary DI / UDI-DI
08058480560011
Basic UDI-DI
805848056SAGMJW
EMDN Code
B010201 Whole blood, red blood cells or plasma 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
  • CMR Substance
  • Endocrine Disruptor
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 3c15c95a-85cb-4292-bf24-c65b3d11e0a3 61 fields · synced 22 Oct 2026