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0.3 Haemoconcentrator Tubing Pack

by Chalice Medical Ltd United Kingdom EUDAMED

Ref CME90019Model Haemoconcentrator Set

EMDN F0301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060491611517 Basic UDI-DIDate12 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Haemoconcentrator Set, CME90019
Primary DI / UDI-DI
05060491611517
Basic UDI-DI
B-05060491611517
EMDN Code
F0301 Haemofiltration-haemodiafiltration kits
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000010617
Authorised representative
Chalice Medical Europe GmbH DE-AR-000007891

Other devices from Chalice Medical Ltd

See all devices from Chalice Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9192ae72-e68e-4e0f-a50b-833b89be8f50 61 fields · synced 23 Oct 2026