CE Certification
COMESTAI CHECK — Class I Medical Device
Last updated: 24 July 2026
CE
Class I Medical Device
The ComeStai Check app is a Class I medical device, CE-marked in accordance with Regulation (EU) 2017/745 on medical devices (MDR). For Class I devices, conformity is declared by the manufacturer under its own responsibility, without the involvement of a Notified Body.
Intended use
Device for the detection of physiological data.
Device identification data
| Commercial name | COMESTAI CHECK |
|---|---|
| Risk class | Class I Medical Device (MDR — Reg. EU 2017/745) |
| Marking | CE |
| UDI-DI | 8059529510004 |
| CND code | Z12040182 |
| Italian Ministry of Health registration | R/2741800 |
| EUDAMED — manufacturer SRN | IT-MF-000048496 |
| Quality management system | ISO 13485:2016 — certificate no. 1261-2025, expiry 02/11/2028 |
The regulatory identifiers (UDI-DI, CND, registration number, SRN) are shown on the device label and do not vary between language versions.
Manufacturer
Come Stai S.p.A.
Via A. Rizzoli, 4 — 20132 Milan, Italy
PEC: comestai@pecplus.it