Skip to content

Haemodialysis Devices

by Jihua Medical Apparatus & Instruments Co., LTD. Guangzhou China EUDAMED

Ref 93/42/EECModel JHM-2028、JHM-2028A、JHM-2028B、JHM-2028M、JH-4048、JH-5058, JHM-2028

EMDN F900299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975274281018 Basic UDI-DIDate9 May 2023RegisteredStatusActive

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
JHM-2028、JHM-2028A、JHM-2028B、JHM-2028M、JH-4048、JH-5058, 93/42/EEC, JHM-2028
Primary DI / UDI-DI
06975274281018, 06975274281001
Basic UDI-DI
B-06975274281018, B-06975274281001
EMDN Code
F900299 Vascular access devices (only for haemodialysis) - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000023822
Authorised representative
Lotus NL B.V. NL-AR-000000121

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 (2)

  • EUDAMED d0b691c2-9ab2-4f35-b417-4c68439f01d0 61 fields · synced 22 Oct 2026
  • EUDAMED 06975274281001|B-06975274281001 61 fields · synced 19 May 2026