Bisolnatural 3 in1 sans sucre /Zonder suiker / ohne Zucker 100 ml BE

Organization name

Labomar S.p.A.

SRN

IT-MF-000007965

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor. Do not take it if you are allergic, intolerant or hypersensitive to any component. The device contains glycerol which can cause headaches and mild digestive disorders (diarrhea). Do not use the product after the expiry date printed on the package. Keep out of the reach of children. Do not use for purposes other than that for which the product is intended. No side effects associated by used the device have been observed , if you notice the appearance of side effects, inform your doctor. Expiry date refers to the product in its intact packaging, and properly stored. In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use. Do not administer the product to children under two years of age Do not exceed the recommended daily dose Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution due to lack of experimental data. Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding. In any case, consult your doctor before taking it. Do not use in case the package is not intact. The period of validity after the first opening of the syrup is 12 weeks. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Autorithy. In case of any undesired event always seek for medical advice.

Primary placement in Belgium; available across 1 country total.

Trade name

Bisolnatural 3 in1 sans sucre /Zonder suiker / ohne Zucker 100 ml BE

UDI-DI code

08056300620808

Basic UDI-DI

805630062FTPR659U

Reference / catalog number

FTPR65

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Bisolnatural 3 in1 sans sucre /Zonder suiker / ohne Zucker, is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of wet and dry cough, throat irritation. Bisolnatural 3 in1 sans sucre /Zonder suiker / ohne Zucker is for children (2+) and adults.

Additional information URL

https://labomar.com/en/products/ftpr65/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

Certificate health across this manufacturer's portfolio.