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Polysulfone Hollow Fiber Hemodialyzers

by Allmed Middle East 32 variants

Ref PLATINUM H2Model PLATINUM H1 PLATINUM H2 PLATINUM H2X PLATINUM H3 PLATINUM H4 PLATINUM H5 PLATINUM H6

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 Number6221166PSSTHDF3R Basic UDI-DI 06221166007663UDI-DIDate13 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  • Withdrawn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
PLATINUM H1 PLATINUM H2 PLATINUM H2X PLATINUM H3 PLATINUM H4 PLATINUM H5 PLATINUM H6, PLATINUM H2
Primary DI / UDI-DI
06221166007663
Basic UDI-DI
6221166PSSTHDF3R
Direct Marketing DI
06221166007663
EMDN Code
F01060303 DIALYSERS - UFC > 35 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