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Polysulfone Hollow Fiber Hemodialyzers

by Allmed Middle East 32 variants

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

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 Number6221166PSSTHDXX Basic UDI-DI Date13 Jun 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  • Withdrawn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
Polysulfone Hollow Fiber Hemodialyzers
Model / Reference
PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220, M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS, PS 220, PS 100 PS 130 PS 140 PS 160 PS 180 PS 200 PS 220 M1HPS M2HPS M2XHPS M3HPS M4HPS M5HPS M6HPS
Primary DI / UDI-DI
06221166006611, 06221166006604
Basic UDI-DI
6221166PSSTHDXX, 6221166PSRHDWK
Direct Marketing DI
06221166006611
06221166006604
EMDN Code
F01060103 DIALYSERS - UFC < 18 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
EU 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