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Sikun 2000 Pro

by Sikun Life Science Co., Ltd. China EUDAMED

Ref 5098, 5067Model Gene Sequencer (Sikun 2000 & Sikun 1000 & Sikun 500 & Sikun 2000 pro & Sikun 1000 pro & Sikun 500 pro)

EMDN W02050115

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model01F9 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Sikun 2000 Pro
Sikun 2000
Device Name
Gene Sequencer
Model / Reference
Gene Sequencer (Sikun 2000 & Sikun 1000 & Sikun 500 & Sikun 2000 pro & Sikun 1000 pro & Sikun 500 pro), 5098, 5067
Primary DI / UDI-DI
06975608185098, 06975608185067
Basic UDI-DI
697560818model01F9
EMDN Code
W02050115 DNA synthesizers
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 (2)

  • EUDAMED 3c0cf87d-5329-46df-89a4-d91024d3d033 61 fields · synced 22 Oct 2026
  • EUDAMED 06975608185067|697560818MODEL01F9 61 fields · synced 18 May 2026