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Huma-kinexus

by Huma Therapeutics Limited

Ref 80011Model V1.0

Active European Union

CE MDR

Valid until

1 Mar 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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/MDR Number++G28780011LU Basic UDI-DI G28780011UDI-DIDate11 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000316138 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    9 Jul 2026
    Expires
    1 Mar 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Huma-kinexus
Model / Reference
V1.0, 80011
Primary DI / UDI-DI
G28780011
Basic UDI-DI
++G28780011LU
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
GB-MF-000031420
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Huma Therapeutics Limited

  • Huma

    Class IIb

  • Huma

    Class IIb

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No