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Fully automatic library preparation system

by AMTK Inc. EUDAMED

Active European Union

Ref iLab-100

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697833121iLab-100U6 Basic UDI-DIDate5 Mar 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  • Withdrawn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

Model / Reference
iLab-100
Primary DI / UDI-DI
06978331210006
Basic UDI-DI
697833121iLab-100U6
Direct Marketing DI
06978331210006
EMDN Code
W02060199 Robotic sample processing systems - other
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000046792
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from AMTK Inc.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No