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Hollow Fiber Dialyzer

by Shandong Weigao Blood Purification Products Co., Ltd. EUDAMED

Active European Union

Ref TCZ0117Model F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23H

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69477933Dialyzer019J Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23H, TCZ0117
Primary DI / UDI-DI
56947793310130
Basic UDI-DI
69477933Dialyzer019J
Unit of Use DI
06947793310135
EMDN Code
F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000012203
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

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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