Skip to content

Analysis Software for Human 6 Gene Methylation and Alpha-Fetoprotein Combinatorial Detection Data

by Genetron (Wuxi) Biotech Co., Ltd. EUDAMED

Active European Union

Ref SPQ002

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06980133260004 Basic UDI-DIDate29 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  • Withdrawn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

Model / Reference
SPQ002
Primary DI / UDI-DI
06980133260004
Basic UDI-DI
B-06980133260004
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000055452
Authorised representative
MedPath GmbH DE-AR-000000087

Properties

  • Professional Testing

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
  • Surgical Instrument: No