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Specimen Collection Kit

by Agendia N.V Netherlands EUDAMED

Ref DNS109.01

EMDN W05020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0850024841DNSZ3 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
DNS109.01
Primary DI / UDI-DI
00850024841420
Basic UDI-DI
0850024841DNSZ3
Direct Marketing DI
00850024841420
EMDN Code
W05020102 Samples transport, boxes
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000011684

Other devices from Agendia N.V

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • 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
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 9b177f4e-f8d1-4267-b550-bfecc1872ad8 61 fields · synced 23 Oct 2026