Skip to content

Aitis Skin Cancer App

by Aiti Solutions BV Netherlands EUDAMED

Ref 01AITISCA26 EMDN Z12040292

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number11032608721249265341X4 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  • Withdrawn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

Device Name
Aitis Skin Cancer App
Model / Reference
01AITISCA26
Primary DI / UDI-DI
08721249265341
Basic UDI-DI
11032608721249265341X4
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class I
Medical Purpose
The Skin Cancer APP helps users photograph, organize, and track visible skin marks over time using advanced artificial intelligence. By simply taking a photo of moles and other skin features the app provides structured insights to help users better understand visible skin changes. Using image analysis technology, the app offers reference-based risk indicators and educational content about a variety of skin conditions, such as: Melanoma Basal cell carcinoma Squamous cell carcinoma Benign moles (naevi) Seborrheic keratoses

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 692b1945-5224-4e80-a50d-bf04eca0c652 61 fields · synced 22 Oct 2026