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KMRtrack® Monitoring Kit

by Genome Diagnostics B.V.

Ref 8842982

Active European Union

CE IVDD

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/IVDD NumberB-88429825A Basic UDI-DI D-88429825AUDI-DIDate28 May 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
8842982
Primary DI / UDI-DI
D-88429825A
Basic UDI-DI
B-88429825A
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000453

From the manufacturer

Manufacturer's product page: KMRtype/KMRtrack Assay

Other devices from Genome Diagnostics B.V.

See all devices from Genome Diagnostics B.V. →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No