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Biopure Hollow Fiber Haemodialyzers

by Allmed Middle East 20 variants

Ref BIOPURE 220 HFModel BIOPURE 100 HF BIOPURE 130 HF BIOPURE 160 HF BIOPURE 180 HF BIOPURE 200 HF BIOPURE 220 HF BIOPURE 240 HF BIOPURE 260 HF

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221166PUREMASTHDF48 Basic UDI-DI 06221166006451UDI-DIDate14 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  • Withdrawn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
Biopure Hollow Fiber Haemodialyzers
Model / Reference
BIOPURE 100 HF BIOPURE 130 HF BIOPURE 160 HF BIOPURE 180 HF BIOPURE 200 HF BIOPURE 220 HF BIOPURE 240 HF BIOPURE 260 HF, BIOPURE 220 HF
Primary DI / UDI-DI
06221166006451
Basic UDI-DI
6221166PUREMASTHDF48
Direct Marketing DI
06221166006451
EMDN Code
F01060303 DIALYSERS - UFC > 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