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Hollow Fiber Dialyzer

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

Ref TCD0116Model 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 EMDN F01060203

Regulatory status

as of 25 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  • Withdrawn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 · synced 25 Oct 2026

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, TCD0116
Primary DI / UDI-DI
56947793304474
Basic UDI-DI
69477933Dialyzer019J
Unit of Use DI
06947793304479
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

Other devices from Shandong Weigao Blood Purification Products Co., Ltd.

See all devices from Shandong Weigao Blood Purification Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 56947793304474|69477933DIALYZER019J 61 fields · synced 25 Oct 2026