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Apheresis Needle Assembly for Single Use

by Zhengyuan Technology co.,Ltd. China EUDAMED

Ref 2104, 2112, 2113, 2128

EMDN B030199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974836880225 Basic UDI-DIDate6 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
2104, 2112, 2113, 2128
Primary DI / UDI-DI
06974836880225, 16974836881281, 06974836880577, 06974836880287, 06974836880584, 16974836881571, 16974836882288
Basic UDI-DI
B-06974836880225, B-16974836881281, B-06974836880577, B-06974836880287, B-06974836880584, B-16974836881571, B-16974836882288
EMDN Code
B030199 Apheresis collection devices - other
Device Class
Class IIa
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 (7)

  • EUDAMED 1f8b869c-b843-460c-b36b-246521333b84 61 fields · synced 22 Oct 2026
  • EUDAMED 16974836881281|B-16974836881281 61 fields · synced 17 May 2026
  • EUDAMED 06974836880577|B-06974836880577 61 fields · synced 17 May 2026
  • EUDAMED 06974836880287|B-06974836880287 61 fields · synced 18 May 2026
  • EUDAMED 06974836880584|B-06974836880584 61 fields · synced 19 May 2026
  • EUDAMED 16974836881571|B-16974836881571 61 fields · synced 19 May 2026
  • EUDAMED 16974836882288|B-16974836882288 61 fields · synced 19 May 2026