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Aia-Pack Multi Analyte Control

by Tosoh Europe N.V. Belgium EUDAMED

Ref 0960474Model AIA-PACK MULTI ANALYTE CONTROL EMDN W01021521

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430000495000960474SA Basic UDI-DIDate19 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
AIA-PACK MULTI ANALYTE CONTROL, 0960474
Primary DI / UDI-DI
04562185380095
Basic UDI-DI
5430000495000960474SA
EMDN Code
W01021521 Multicomponent immunochemistry controls
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000210

Other devices from Tosoh Europe N.V.

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED d25e27ea-7132-4bfe-a326-7b445a454b3f 61 fields · synced 22 Oct 2026