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Polysulfone Hollow Fiber Hemodialyzers

by Allmed Middle East EUDAMED

Active European Union

Ref M5HPSModel PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220 M1HPS M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS, PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220, M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221166PSRHDWK Basic UDI-DIDate13 Jun 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  • Withdrawn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

Device Name
Polysulfone Hollow Fiber Hemodialyzers
Model / Reference
PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220 M1HPS M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS, M5HPS, PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220, M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS
Primary DI / UDI-DI
06221166006970, 06221166007809
Basic UDI-DI
6221166PSRHDWK, 6221166PSSTHDXX
Direct Marketing DI
06221166006970
06221166007809
EMDN Code
F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
EG-MF-000025747
Authorised representative
Allmed Medical GmbH DE-AR-000007830

Other devices from Allmed Middle East

See all devices from Allmed Middle East →

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