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Healthentia v4

by Innovation Sprint SRL

Ref Healthentia v4Model v4

Active European Union

CE MDR

Valid until

17 Dec 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Kiwa Assurance B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number21M00098SUP01 Date24 Oct 2025IssuedStatusActive expires 17 Dec 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 21M00098SUP01 Active Supplemented

    Quality management system EU MDR

    Certifier
    Kiwa Assurance B.V. 1912
    Issued
    24 Oct 2025
    Expires
    17 Dec 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Healthentia
Model / Reference
v4, Healthentia v4
Primary DI / UDI-DI
05419980178930
Basic UDI-DI
54199801789HLTv4GY
Direct Marketing DI
05419980178930
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000879

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