FT.CE.107.FB.8.24

Trade name

not provided

D-FT.CE.107.FB.8.24T2

B-FT.CE.107.FB.8.24T2

Reference / catalog number

FT.CE.107.FB.8.24

EUDAMED

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

REFLUSEN is a medical device useful in the symptomatic treatment of all those states linked to gastro-oesophageal reflux (NERD, functional pyrosis, hypersensitive esophagus to acid and non-acid reflux). Its viscous formulation, capable of adhering and covering the esophageal mucosa, forms a protective barrier. Hyaluronic acid, a component naturally present in the extracellular matrices of our body, hydrates and protects the mucous membranes of the gastrooesophageal tract and supports the process of reconstruction of the damaged epithelium. Magnesium Alginate, thanks to its film-forming properties, coats the mucous membranes protecting them from gastric juices, contributing to the reduction of the harmful eects of the same and to the burning sensation and irritation due to reflux episodes.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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

• CW999

  Keep out of reach of children. Avoid contact with eyes. In case of concomitant therapy with other drugs and / or medical devices, consult your doctor before using the product. Do not use the product after the expiration date; the expiry date refers to the intact and properly stored product. For pregnant and lactating women, the use of the product should be limited to cases of real need and under the direct supervision of the doctor. Do not use in case of individual hypersensitivity to the present components. Do not use the product in association with quaternary ammonium compounds. Do not use the product for a period exceeding 30 consecutive days. It is important to inform your doctor or pharmacist of any side eects not described in this package insert. Single-dose product to be used in a single administration. The incorrect observance of the warnings and of the methods of use, as well as the use of a partial dose of the product, could prejudice its eectiveness or be the cause of the aggravation of the existing pathological situation.