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Sun4Health Web Portal

by siHealth Ltd.

Ref Sun4Health Web PortalModel Sun4Health

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506086107SIHS4HAQ Basic UDI-DI 05060861070128UDI-DIDate26 Nov 2023RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Sun4Health
Model / Reference
Sun4Health, Sun4Health Web Portal
Primary DI / UDI-DI
05060861070128
Basic UDI-DI
506086107SIHS4HAQ
Direct Marketing DI
05060861070128
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000034129
Authorised representative
siHealth Photonics S.r.l. IT-AR-000033481

Other devices from siHealth Ltd.

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