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Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)

by Shanghai YJMED BioTechnology Co., Ltd. China EUDAMED

Ref 24 tests/kitModel Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)24 tests/kit EMDN W01060299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977334213083 Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)
Model / Reference
Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)24 tests/kit, 24 tests/kit
Primary DI / UDI-DI
06977334213083
Basic UDI-DI
B-06977334213083
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
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
  • Reagent
  • Professional Testing
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 34992081-3e52-4f35-af67-014b61155fc1 61 fields · synced 24 Oct 2026