The EC mark is established under the Medical Devices Regulation – MDR 2017/745.
For further information please contact:
regulatory@bhl-medical.com
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
All incidents are investigated to identify the causes and prevent them from recurring, namely through implementation of corrective security measures, if necessary, to minimise the risk arising from the use of the devices.
How to notify?
Notifications of adverse reactions / incidents / undesirable effects with products manufactured by BHL-Medical can be made through sending information to the following contacts:
Address: Estrada da Avessada no. 390 – 2665-402 – Santo Estêvão das Galés – Portugal
Phone: +351 219821694
Email: incident.report@bhl-medical.com
User information
All information / questions about medical devices placed on the market can be requested from the manufacturer BHL-Medical.
Instructions for Use
For additional information
The request for additional information may be directed to the following contacts:
Address: Estrada da Avessada no. 390 – 2665-402 – Santo Estêvão das Galés – Portugal
Phone: +351 219821694
Email: quality@bhl-medical.com