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MSI digital PCR detection kit

by TargetingOne Technology (Beijing) Corporation China EUDAMED

Ref 12690-2Model MS01-Y24

EMDN W01060214

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974689627206 Basic UDI-DIDate9 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MS01-Y24, 12690-2
Primary DI / UDI-DI
06974689627206
Basic UDI-DI
B-06974689627206
EMDN Code
W01060214 Colorectal cancer (msi-h / dmmr)
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028247
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from TargetingOne Technology (Beijing) Corporation

See all devices from TargetingOne Technology (Beijing) Corporation →

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 8e1b3255-b17b-49b1-b313-f75ffe07b124 61 fields · synced 24 Oct 2026