FLAEM AirFeel Manual De Instrucciones De Uso página 17

COMMUNICATION OF SERIOUS EVENTS
Serious events that occur in relation to this product must be reported immediately to the
manufacturer or the competent authority. An event is considered serious if it causes or
may cause, directly or indirectly, death or an unexpected and serious deterioration in a
person's state of health.
COUNTRY
Ireland
Malta
SYMBOLS PRESENT ON THE DEVICE OR ON THE PACKAGE
Medical device
Manufacturer
Date of production
CE marking ref. regulation
2017/745 EU and subsequent
updates
Free from phthalates and
bisphenol
Temperature limits
Atmospheric pressure limits
Multiple use per single patient
AUTHORITY
Health Products Regulatory Authority
Kevin O'Malley House, Earlsfort Centre, Earlsfort
Terrace, IE - Dublin 2
E-mail: devicesafety@hpra.ie
Medical Devices Unit Medicines Authority
Sir Temi Żammit Buildings, Malta Life Sciences Park
San Ġwann SĠN 3000
E-mail : devices.medicinesauthority@gov.mt
Consult the instructions for use
Model number
Lot code
Unique identifier of the device
Humidity limits
Attention
Sphere lock
Sphere unlock
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