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Hollow Fiber Dialyzer

by Guangdong Zhongai Medical Technology Co., Ltd. 9 variants

Ref HS16Model HS10,HS12,HS13,HS14,HS16,,HS17,HS18,HS19,HS20,HS21,HS22,HS24

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6979848020000H7 Basic UDI-DI 06979848020041UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
HS10, HS12, HS13, HS14, HS16, HS17, HS18, HS19, HS20, HS21, HS22, HS24
Primary DI / UDI-DI
06979848020041
Basic UDI-DI
6979848020000H7
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIa
EU 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

  • 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