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Plasma Component Bags for Single Use

by Zhengyuan Technology co.，Ltd. China EUDAMED

Ref 2147

EMDN B010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974836880539 Basic UDI-DIDate5 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 22 Oct 2026

Model / Reference
2147
Primary DI / UDI-DI
06974836880539, 16974836881533
Basic UDI-DI
B-06974836880539, B-16974836881533
EMDN Code
B010199 Blood collection bags and kits - other
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 (2)

  • EUDAMED d28a18c4-480e-4b8d-831d-289bcf173f71 61 fields · synced 22 Oct 2026
  • EUDAMED 16974836881533|B-16974836881533 61 fields · synced 17 May 2026