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Huma

by Huma Therapeutics Limited 2 variants

Ref HUMAModel V1.38

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000316138 Date9 Jul 2026IssuedStatusActive expires 1 Mar 2028

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  • Withdrawn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
Model / Reference
V1.38, HUMA
Primary DI / UDI-DI
*+G28701/$$71.24T*
Basic UDI-DI
++G287HUMAII7R
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Northern Ireland

Manufacturer details

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

Other devices from Huma Therapeutics Limited

  • Huma-kinexus

    Class IIb

  • Huma

    Class IIb

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No