Skip to content

Aitis Wounds App

by Aiti Solutions BV Netherlands EUDAMED

Ref 01AITISWA26 EMDN Z12040292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number11032608721249265358XM Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
01AITISWA26
Primary DI / UDI-DI
08721249265358
Basic UDI-DI
11032608721249265358XM
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class I
Medical Purpose
The AITIS Wound APP allows users to monitor and document wound progress over time, supporting data-driven decisions to enhance healing outcomes. The AITIS Wound APP requires Organisation pre-registration before use. The app enables users to scan images. It automatically calculates the wound’s dimensions, segments the tissues and calibrates images using proprietary AI algorithms with explainability. It can also provide a PDF report.

Manufacturer details

EUDAMED SRN
NL-PR-000048897

Other devices from Aiti Solutions BV

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 661b14f9-6c3d-4b1a-af6e-e2ab3eabda1d 61 fields · synced 22 Oct 2026