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Hollow fiber hemodialyzer low-flux

by Jiangxi Hongda Medical Equipment Group Ltd. 8 variants

Ref HD-18L-001Model HD-10L，HD-12L，HD-13L，HD-14L，HD-15L，HD-16L，HD-17L，HD-18L，HD-19L，HD-20L

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69207567KXXWTXQ00028Y Basic UDI-DI 66920756718577UDI-DIDate30 Mar 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  • Withdrawn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
HD-10L，HD-12L，HD-13L，HD-14L，HD-15L，HD-16L，HD-17L，HD-18L，HD-19L，HD-20L, HD-18L-001
Primary DI / UDI-DI
66920756718577
Basic UDI-DI
69207567KXXWTXQ00028Y
EMDN Code
F01060103 DIALYSERS - UFC < 18 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000006019
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.

See all devices from Jiangxi Hongda Medical Equipment Group 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