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Plasma Separators For Single Use

by Zhengyuan Technology co.,Ltd. China EUDAMED

Ref 2405

EMDN B030201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-16974836881052 Basic UDI-DIDate7 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
2405
Primary DI / UDI-DI
16974836881052
Basic UDI-DI
B-16974836881052
EMDN Code
B030201 Plasmapheresis devices and kits
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000032651
Authorised representative
Scinomed Deutschland GmbH DE-AR-000016022

Other devices from Zhengyuan Technology co.,Ltd.

See all devices from Zhengyuan Technology co.,Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
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 adfa4511-abfd-419f-a328-400114a2bbea 61 fields · synced 23 Oct 2026