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Hemodialysis Equipments

by SWS Hemodialysis Care Co., Ltd. China EUDAMED

Ref SWS-4000, SWS-4000A, SWS-5000, SWS-5000A, SWS-5000B, SWS-6000, SWS-6000AModel SWS-4000, SWS-4000A, SWS-5000, SWS-5000A, SWS-5000B, SWS-6000, SWS-6000A

EMDN Z12090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-CNMF00002451669557484HC Basic UDI-DIDate3 Jul 2025RegisteredStatusActive

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
SWS-4000, SWS-4000A, SWS-5000, SWS-5000A, SWS-5000B, SWS-6000, SWS-6000A
Primary DI / UDI-DI
D-CNMF00002451669557484HC
Basic UDI-DI
B-CNMF00002451669557484HC
EMDN Code
Z12090201 Haemodialysis equipment
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024516
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from SWS Hemodialysis Care Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • 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 9b57a1eb-c449-4fe1-9752-9ed6345d9dd9 61 fields · synced 22 Oct 2026