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Sequencing Reagent Kit

by Sikun Life Science Co., Ltd. 52 variants

Ref 0994Model RT-10, RT-30, RT-50, RT-80, RT-160

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model04FF Basic UDI-DI 06975608180994UDI-DIDate15 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
RT-10, RT-30, RT-50, RT-80, RT-160, 0994
Primary DI / UDI-DI
06975608180994
Basic UDI-DI
697560818model04FF
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
EU 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

  • 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