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YJSeq 300 Dx Sequencing System

by Shanghai YJMED BioTechnology Co., Ltd. China EUDAMED

Ref YJSeq 300 Dx EMDN W02050199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697733421YJ300KJ Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
YJSeq 300 Dx
Primary DI / UDI-DI
06977334213014
Basic UDI-DI
697733421YJ300KJ
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000055692
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shanghai YJMED BioTechnology Co., Ltd.

See all devices from Shanghai YJMED BioTechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06977334213014|697733421YJ300KJ 61 fields · synced 25 Oct 2026