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Aminal Bc/3 -1, 25 5 L

by ALKALOID AD Skopje North Macedonia EUDAMED

Ref 1005658

EMDN F040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05310001217587 Basic UDI-DIDate30 Jan 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
1005658
Primary DI / UDI-DI
05310001217587
Basic UDI-DI
B-05310001217587
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 96d2c5eb-576d-4955-9a27-1dad1c98b57b 61 fields · synced 22 Oct 2026