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Septin9 Gene Methylation Detection Kit for Human Colorectal Cancer (Real-Time PCR)

by BioChain (Beijing) Science & Technology, Inc. EUDAMED

Active European Union

Ref M-0002Model 30 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970110910022 Basic UDI-DIDate13 May 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  • Withdrawn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

Device Name
Septin9 Gene Methylation Detection Kit for Human Colorectal Cancer (Real-Time PCR)
Model / Reference
30 tests/kit, M-0002
Primary DI / UDI-DI
06970110910022
Basic UDI-DI
B-06970110910022
EMDN Code
W01060214 Colorectal cancer (msi-h / dmmr)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000038431
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Biochain (Beijing) Science Technology, Inc.

Properties

Show properties
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No