IT MOH

Italy MOH — BD/RDM Registration

Registration in the Italian Ministry of Health's Banca Dati / Repertorio Dispositivi Medici (BD/RDM) is required for medical devices placed on the Italian market under Regulation (EU) 2017/745 (MDR).

Manufacturer & Medical Device

Manufacturer Teltonika Telemedic UAB Ukmergės g. 120-1, Vilnius, Lithuania	Single Registration Number (SRN) LT-MF-000007642
Device Name MyHealth App	Trade Name MYHEALTH APP
Manufacturer Code MH001	Device Type Medical Device Software

Classification & Applicable Regulation

The device is classified as Class IIa medical device according to Regulation (EU) 2017/745 (MDR) on medical devices.

This Declaration of Conformity is issued under Regulation (EU) 2017/745 of the European Parliament and of the Council.

We, Teltonika Telemedic UAB, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of Regulation (EU) 2017/745. The device has been assessed according to the applicable conformity assessment procedure and is eligible to bear the CE marking.

Registration Information

The device is registered in the Italian Ministry of Health Medical Device Database (BD/RDM):

Field	Details
BD/RDM Registration Identifier	2676270
Registered in the Repertory	Yes
Code Assigned by Manufacturer / Assembler	MH001
Trade Name / Model	MYHEALTH APP
National Classification of Medical Devices (CND)	Z12030692 – Telemetry equipment for vital parameters – Medical device software
Regulation / Legislation	Regulation (EU) 2017/745 (Medical Device Regulation – MDR)
CLASSE CE	R2A - CLASSE IIA
Date of First Publication	15/10/2024
Company Role	Manufacturer
Manufacturer Name	TELTONIKA TELEMEDIC UAB
VAT Number	100013091815
Country	Lithuania

External Links

🏥 Ministero della Salute — BD/RDM Registration of Medical Devices →