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Aminal-Bc/3-1, 50 5 L

by ALKALOID AD Skopje North Macedonia EUDAMED

Ref 1005656

EMDN F040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05310001217563 Basic UDI-DIDate12 Feb 2026RegisteredStatusActive

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 22 Oct 2026

Device Name
Concentrate for Haemodialysis
Model / Reference
1005656
Primary DI / UDI-DI
05310001217563
Basic UDI-DI
B-05310001217563
EMDN Code
F040101 Dialysis concentrates, acid solutions, non-sterile
Device Class
Class IIb
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
MK-MF-000027533
Authorised representative
ALKALOID - INT družba za trgovino in storitve d.o.o. SI-AR-000024261

Other devices from ALKALOID AD Skopje

See all devices from ALKALOID AD Skopje →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • 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 e82af0fc-2444-4af4-a106-2a2f0fbfd722 61 fields · synced 22 Oct 2026