Skip to content

Polyethersulfone Hollow Fiber Hemodialyzers (BIOPURE LFX and HFX)

by Allmed Middle East 14 variants

Ref BIOPURE 180 LFXModel BIOPURE 100 LFX BIOPURE 130 LFX BIOPURE 140 LFX BIOPURE 160 LFX BIOPURE 180 LFX BIOPURE 200 LFX BIOPURE 220 LFX

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 Number6221166BIOPURELFXSTHDYR Basic UDI-DI 06221166012766UDI-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  • Withdrawn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
Polyethersulfone Hollow Fiber Hemodialyzers (BIOPURE LFX and HFX)
Model / Reference
BIOPURE 100 LFX BIOPURE 130 LFX BIOPURE 140 LFX BIOPURE 160 LFX BIOPURE 180 LFX BIOPURE 200 LFX BIOPURE 220 LFX, BIOPURE 180 LFX
Primary DI / UDI-DI
06221166012766
Basic UDI-DI
6221166BIOPURELFXSTHDYR
Direct Marketing DI
06221166012766
EMDN Code
F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
EU market of registration
Germany

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