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High Flux Hemodialyzer

by Jafron Blood Purification Technologies Co., Ltd China EUDAMED

Ref JM-12HModel JM-10H/JM-11H/JM-12H/JM-13H/JM-14H/JM-15H/JM-16H/JM-17H/JM-18H/JM-19H/JM-20H/JM-21H/JM-22H EMDN F01060303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697355616HFHT8 Basic UDI-DIDate8 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
High Fliux Hemodialyzer
Model / Reference
JM-10H/JM-11H/JM-12H/JM-13H/JM-14H/JM-15H/JM-16H/JM-17H/JM-18H/JM-19H/JM-20H/JM-21H/JM-22H, JM-12H
Primary DI / UDI-DI
06973556160372
Basic UDI-DI
697355616HFHT8
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006021
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jafron Blood Purification Technologies Co., Ltd

See all devices from Jafron Blood Purification Technologies Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1edb3654-7e22-47eb-8ff0-c0e2639ed8f5 61 fields · synced 24 Oct 2026