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SmartPDT-P iOS

by siHealth Ltd. United Kingdom EUDAMED

Ref SmartPDT-P iOSModel SmartPDT EMDN Z12040292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506086107SIHSDTCV Basic UDI-DIDate13 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
SmartPDT
Model / Reference
SmartPDT, SmartPDT-P iOS
Primary DI / UDI-DI
05060861070012
Basic UDI-DI
506086107SIHSDTCV
Direct Marketing DI
05060861070012
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 3677e241-9348-4276-866b-fc06caa1a292 61 fields · synced 25 Oct 2026