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Norma Autoloader accessory unit for automated sample vial loading

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref NICA-AL50Model Norma Autoloader

EMDN W02060102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062AutoloaderGH Basic UDI-DIDate6 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Norma Autoloader, NICA-AL50
Primary DI / UDI-DI
05999106200047
Basic UDI-DI
59991062AutoloaderGH
Direct Marketing DI
05999106200047
EMDN Code
W02060102 Automated sample transport systems
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014244

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Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED cff8f122-0bdf-4c48-be1c-51e9782e2872 61 fields · synced 22 Oct 2026