The EC mark is established under the Directive 93/42/EC with the following scope: Non active devices for injection and infusion.
For further information please contact:
regulatory@bhl-medical.com
Incident: adverse or undesirable occurrence related to the use of a medical device, likely to cause death, deterioration of health status, or endanger the health of the patient, the user or public health.
All incidents are investigated in order 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