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KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation and FIT Combined Detection Analysis Software

by Hangzhou New Horizon Health Technology Co., Ltd.

Ref /Model akbbnf01 for windows

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697198037017MR Basic UDI-DI 06971980730178UDI-DIDate9 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation and FIT Combined Detection Analysis Software
Model / Reference
akbbnf01 for windows, /
Primary DI / UDI-DI
06971980730178
Basic UDI-DI
697198037017MR
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class A
Special Device Type
Software
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000027517
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hangzhou New Horizon Health Technology Co., Ltd.

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Properties

  • Professional Testing
  • Surgical Instrument

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
  • New Device: No