FLAEM Rhino Clear RC1-1 Manual De Instrucciones De Uso página 16

NOTIFICATION OF SERIOUS EVENTS
Serious events occurring in connection with 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
unforeseen serious deterioration in a person's state of health.
COUNTRY AUTHORITY
Health Products Regulatory Authority - Kevin O'Malley House,
Ireland Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: devicesafety@hpra.ie
Medical Devices Unit Medicines Authority - Sir Temi Żammit Build-
Malta ings, Malta Life Sciences Park - San Ġwann SĠN 3000
E-mail : devices.medicinesauthority@gov.mt
SYMBOLS ON THE DEVICE OR ON THE PACKAGING
Medical CE marking ref. regula-
tion 2017/745 EU as amended
Phthalate- and bisphenol-free
Model number
Temperature limits
Atmospheric pressure limits
Moisture limits
LOT
Batch Number
INFORMATION ON RESTRICTIONS OR INCOMPATIBILITIES
WITH CERTAIN SUBSTANCES.
• Interactions: The materials used in the device are biocompatible materials and comply with
statutory regulations, however possible allergic reactions cannot be completely ruled out.
• Use the medicine as soon as possible once it has been opened and avoid leaving it in the
nasal douche; once therapy has ended, do not leave the medicine inside the nasal douche
and carry out hygienic preparation.
Manufacturer
Attention
Type BF applied part
Medical device
Unique device identifier
Production date
Check the instructions for use
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