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Hollow Fiber Dialyzer

by Guangdong Zhongai Medical Technology Co., Ltd. China EUDAMED

Ref HS10Model HS10,HS12,HS13,HS14,HS16,,HS17,HS18,HS19,HS20,HS21,HS22,HS24

EMDN F01060303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6979848020000H7 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HS10, HS12, HS13, HS14, HS16, HS17, HS18, HS19, HS20, HS21, HS22, HS24
Primary DI / UDI-DI
06979848020003
Basic UDI-DI
6979848020000H7
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000010088
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Guangdong Zhongai Medical Technology Co., Ltd.

See all devices from Guangdong Zhongai Medical Technology 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 ed40a680-1340-4655-aef1-7fa1598a8ff1 61 fields · synced 22 Oct 2026