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IColocomf

by Wuhan Ammunition Life-tech Co., Ltd. China EUDAMED

Ref AD01-48CE, AD01-96CEModel 48 tests/kit, 96 tests/kit

EMDN W01060214

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-AD01-48CE63 Basic UDI-DIDate9 Sep 2024RegisteredStatusActive

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 22 Oct 2026

Device Name
Stool DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)
Model / Reference
48 tests/kit, AD01-48CE, 96 tests/kit, AD01-96CE
Primary DI / UDI-DI
D-AD01-48CE63, D-AD01-96CE6U
Basic UDI-DI
B-AD01-48CE63, B-AD01-96CE6U
EMDN Code
W01060214 Colorectal cancer (msi-h / dmmr)
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000037251
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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 (2)

  • EUDAMED 4de5256e-63a7-4556-99aa-60ebbb118cbe 61 fields · synced 22 Oct 2026
  • EUDAMED 804cd52d-b643-4a24-840a-93362fd497f8 61 fields · synced 17 May 2026