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Sequencing Reagent Kit

by Sikun Life Science Co., Ltd. China EUDAMED

Ref 512

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model02FB Basic UDI-DIDate31 Aug 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
512
Primary DI / UDI-DI
06975608180512
Basic UDI-DI
697560818model02FB
EMDN Code
W010699 Genetic tests - 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
  • Reagent
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06975608180512|697560818MODEL02FB 61 fields · synced 24 Oct 2026