MDR information for Solo Input Devices
This page provides information for resellers of the Solo range of Input Devices in compliance with Medical Devices Regulation MDR 2017/745.
Declaration of Conformity
Classification
Class 1 Medical Device
Intended Use
The Solo range of assistive input devices are designed to enable a person with an injury, impairment or disability to control and operate IT equipment such as computers, mobile phones, tablets, Smart TVs and communication aids. Solo input devices are for indoor use only.
Legal Manufacturer
Unique Perspectives Limited
Ballyline
Callan
Co. Kilkenny
IRELAND
EU
R95D9E8
Rep of Ireland Company Registration Number
286087
EUDAMED Single Registration Number (SRN)
Global Model Number (BUDI-DI/GMN)
Global Trade Identification Numbers (UDI-DI/GTIN)
5392001005616 – Solo Button
5392001005623- Solo Mouse
5392001005630- Solo Touch
5392001005647- Solo Wheel
Device Identification (placed on packaging)
(01) GTIN + (11) Production Date (YYMMDD) + (21) Device serial Number
Global Medical Device Nomenclature (GMDN)
Description: “Assistive mouse-control training device”
Code: 30967
European Medical Device Nomenclature (EMDN)
Description: “MOUSE AND KEYBOARD EMULATORS”
Code:Y210906
Rep. of Ireland Regulatory Authority:
Health Products Regulatory Authority (HPRA)
Earlsfort Centre
Dublin 2
HPRA Company Reference number
IE/CA01/M/GM/0501
HPRA Device Reference Number
IE/CA01/M/GM/0501/xxxxx
Applied Standards
EN 55011: (2009) – E.M.C. requirements for Industrial, Scientific and Medical equipment.
EN 61000-6-1: (2005) – Electromagnetic compatibility (EMC)
User Manuals
http://housemate.ie/wp-content/uploads/2025/06/solo_user_manual_june_2025.pdf
Restrictions of the use of Hazardous Substances
Additional Information & reference documents
MEDDEV 2.7/1 (2016) – Guidelines on Medical Devices / Clinical Evaluation: A guide for manufacturers and Notified Bodies
MDCG 2020-5 (2020) – Clinical Evaluation – Equivalence: A guide for manufacturers and Notified Bodies
MEDDEV 2.4/1 (2010) – Guidelines for the classification of Medical Devices
ISO 13485 (2016) – Medical device – Quality management system – Requirements for regulatory purposes
ISO 14971 (2019) – Medical devices – Application of risk management to medical devices