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Autosampler NG accessory unit for automated sample vial loading

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref HE0350Model 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

Device Name
Norma Autoloader accessory unit for automated sample vial loading
Model / Reference
Norma Autoloader, HE0350
Primary DI / UDI-DI
05999106200443
Basic UDI-DI
59991062AutoloaderGH
Direct Marketing DI
05999106200443
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 0d08487a-95a2-4bd8-b87e-607cb23eed02 61 fields · synced 22 Oct 2026