REFLUSOD

Organization name

GRUPPO FARMAIMPRESA SRL

SRN

IT-MF-000012625

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW999

  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 components present. 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. Incorrect compliance with warnings and instructions for use, as well as direct use by more than one person of the dosing syringe, could compromise the eectiveness of the product or cause the aggravation of existing problems or cause problems to occur before not present. Consume the product within 3 months of opening.

Primary placement in Italy; available across 1 country total.

Trade name

REFLUSOD

UDI-DI code

D-FT.CE.107.FH.2.2105A

Basic UDI-DI

B-FT.CE.107.FH.2.2105A

Reference / catalog number

FT.CE.107.FH.2.210

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

REFLUSOD 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 gastro-oesophageal tract and supports the process of reconstruction of the damaged epithelium. The Simethicone, thanks to its chemical-physical properties, reduces the surface tension of the gases present in the gastric liquid, favoring their elimination. This process moderates the pressure that the gases exert on the gastric fluid responsible for reflux. Sodium alginate creates a viscous barrier capable of preventing the contents of the stomach from rising towards the esophagus.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-FT.CE.107.FH.2.2105A

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

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