MDR information for HouseMate
This page provides information for resellers of the HouseMate environmental control device in compliance with Medical Devices Regulation MDR 2017/745.
Declaration of Conformity
Classification
Class 1 Medical Device
Intended Use
The HouseMate device compensates for a person’s injury, impairment or disability by enabling them to remotely control appliances in their environment and attain a level of independence that would otherwise be impossible. Such appliances include, but are not limited to, Door opening mechanisms, Heating and Ventilation systems, Lifts and Bed controls, Lighting, Communication devices, Computers and Audio-Visual equipment.
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 Number (UDI-DI/GTIN)
5392000166271
5392000166202 – Easywave version
5392000166288 – Zwave version
Device Identification (placed on packaging)
(01) GTIN + (11) Production Date (YYMMDD) + (21) Device serial Number
Global Medical Device Nomenclature (GMDN)
Description: “Assistive remote control system”
Code: 35465
European Medical Device Nomenclature (EMDN)
Description: “PROGRAMMABLE REMOTE CONTROLS, HOME AUTOMATION SYSTEMS, CONTROL SATELLITES”
Code: Y241203
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/0501/7706
Applied Standards
EN60601-1-2: (2011) Medical electrical equipment – Electromagnetic disturbances
EN 55016-2-3 (2010) & A1 (2010) – Radiated Emissions
EN61000-4-2 (2009) – Electrostatic discharge
Restrictions of the use of Hazardous Substances
User Manual
http://housemate.ie/wp-content/uploads/2021/05/housemate_manual_may_2021.pdf
Additional Information & reference documents
EN ISO 16201 (2006) – Technical aids for disabled persons – Environmental Control Systems for Daily living.
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