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Infusion Supervision System

by Shenzhen Mindray Scientific Co., Ltd. China EUDAMED

Ref BeneFusion nDSModel BeneFusion eDS ex/BeneFusion eDS/BeneFusion nDS ex/BeneFusion nDS

EMDN Z12030306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69469888AB01600029XN Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BeneFusion eDS ex/BeneFusion eDS/BeneFusion nDS ex/BeneFusion nDS, BeneFusion nDS
Primary DI / UDI-DI
06946988800048
Basic UDI-DI
69469888AB01600029XN
EMDN Code
Z12030306 Infusion and syringe pump control systems
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030037
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Scientific Co., Ltd.

See all devices from Shenzhen Mindray Scientific Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c430a44c-3af2-4f7c-8133-6ce3a7a84b98 61 fields · synced 24 Oct 2026