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Hollow Fiber Hemodialyzer high-flux

by Jiangxi Hongda Medical Equipment Group Ltd. 7 variants

Ref HD-19H-001Model HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H

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 Number69207567KXXWTXQ00018W Basic UDI-DI 66920756718089UDI-DIDate13 Jan 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  • Withdrawn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

Device Name
Hollow Fiber Hemodialyzer
Model / Reference
HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H, HD-19H-001
Primary DI / UDI-DI
66920756718089
Basic UDI-DI
69207567KXXWTXQ00018W
EMDN Code
F01060203 DIALYSERS - UFC = 18 - 35 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
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No