Smart Symptom Check (BASIC UDI-DI 64298301792JSTSSYMPTOMCFK) is a software intended to drive the assessment of the need for treatment. Smart Symptom Check provides information to healthcare professionals and patients by generating a summary report on patient’s answers, of patient’s possible conditions, the clinical urgency and care path options appropriate to the situation.

Smart Symptom Check is classified as Class IIa product based on (EU) 2017/745 Annex VIII classification rule 11.

Manufacturer

JST Healthcare Solutions Oy (SRN FI-MF-000011817)

Kaisaniemenkatu 1 C 108, 00100, Helsinki, FINLAND

This declaration of conformity is issued under the sole responsibility of the manufacturer.

Smart Symptom Check is in conformity with Regulation and the relevant Union legislation and harmonised standards:

The requirements specified in Regulation (EU) 2017/745 have been fulfilled in relation to the device that is covered by this Declaration of Conformity.

(EU) 2017/745
EN ISO 13485:2016/A11:2021
EN ISO 14971:2019/A11:2021
EN ISO 15223-1:2021.

Other standards that have been used for Smart Symptom Check:

IEC 62304:2006/A1:2015
EN 82304-1:2017
EN 62366-1:2015/A1:2020
EN ISO 20417:2021
EN ISO/TR 20416:2020

Notified body information

SGS Fimko (0598), conformity assessment procedure in accordance with Route R2a, MDR (EU) 2017/745 Annex IX (Quality Management System Assessment and Assessment of Technical Documentation section 4)

Identification of the certificate: FI25/00000023

Signed for and on behalf of JST Healthcare Solutions Oy

Helsinki, 19.01.2026

Rosa Tengvall, CEO