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NeoMass AAAC

by Labsystems Diagnostics Oy Finland EUDAMED

Ref 7100100

EMDN W01010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06438172400016 Basic UDI-DIDate14 Aug 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
NeoMass AAAC
Model / Reference
7100100
Primary DI / UDI-DI
06438172400016
Basic UDI-DI
B-06438172400016
EMDN Code
W01010402 Multiple substrates only - clin. chem lab r.
Device Class
Class IVD Annex II List B
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000018281

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b672becc-33c6-4ec0-9970-e5bd347e6eb2 61 fields · synced 22 Oct 2026