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Automated Library Preparation System

by Sikun Life Science Co., Ltd. China EUDAMED

Ref 5173Model AISPre 3200, 1600, 3200P

EMDN W02060199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model05FH Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AISPre 3200, 1600, 3200P, 5173
Primary DI / UDI-DI
06975608185173
Basic UDI-DI
697560818model05FH
EMDN Code
W02060199 Robotic sample processing systems - other
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000047921
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sikun Life Science Co., Ltd.

See all devices from Sikun Life Science Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 06975608185173|697560818MODEL05FH 61 fields · synced 24 Oct 2026