Gruppo FarmaImpresa is among the first Italian companies to obtain MDR certifications for some of its substance-based medical devices
Gruppo FarmaImpresa has enthusiastically undertaken the complex MDR certification process because part of its corporate mission is to offer safety and quality first.
This achievement is so significant because we are among the first companies in Italy to have received MDR certifications for some of our substance-based medical devices.
The achievement is the result of a long work we have been doing for two years to ensure the compliance of our medical devices in order to proactively respond to regulatory changes and promote the success of our customers.
Gruppo FarmaImpresa stands not just as a supplier of products and services, but as a true partner with whom we share perspectives and projects.
We have succeeded in developing our processes by making them compliant with current regulatory requirements, thanks to a huge team effort involving many departments and employees.
The medical devices for which we received the first certifications under MDR Class IIb are emulsions in water or oil containing simethicone, in 6 different versions:
Medical Device in aqueous solution in drops:
- 10/20/30/50/100 ml bottle with pump dropper containing an emulsion of Simeticone in aqueous solution (40 mg in 20 drops);
- Indicated in the treatment and prevention in dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colic in infants, children and adults.
Medical Device in aqueous solution spray:
- 20 ml bottle with spray dispenser containing an emulsion of Simethicone in aqueous solution (40 mg in 5 paff);
- Indicated in the treatment and prevention in dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colic in infants, children and adults.
Medical Device in aqueous solution in drops with Saccharomyces Boulardii:
- 20 ml bottle with pump dropper containing an emulsion of simethicone in aqueous solution (40 mg in 20 drops) + 1 2 g stick sachet containing S. boulardii (20 MLD/bst) to be dispersed in the simethicone emulsion at first use;
- Indicated in the treatment and prevention in dyspeptic disorders, gastrointestinal bloating, aerophagia and gas colic caused by intestinal dysbiosis, to decrease the surface tension of the enteric lumen and to restore intestinal flora.
Medical Device in oily solution in drops:
- 10/20/30/50/100 ml bottle with pump dropper containing an emulsion of Simeticone in oil solution (40 mg in 20 drops) with Vitamin E, Coenzyme Q, Silica;
- Indicated in the treatment and prevention in dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colic in infants, children and adults;
- Preservative-free;
- Bubble-Burster: Enhanced antifoaming activity compared with aqueous emulsion;
- Patent-protected formulation.
Medical Device in oily solution spray:
- 20 ml bottle with spray dispenser containing an emulsion of Simethicone in oil solution (40 mg in 5 paff) with Vitamin E, Coenzyme Q, Silica;
- Indicated in the treatment and prevention in dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colic in infants, children and adults;
- Preservative-free;
- Bubble-Burster: Enhanced antifoaming activity compared with aqueous emulsion;
- Patent-protected formulation.
Medical Device in oil solution drops with Saccharomyces Boulardii:
- 20-mL bottle with pump dropper containing an emulsion of Simeticone in oil solution (40 mg in 20 drops) with Vitamin E, Coenzyme Q, Silica + 1 2-g stick sachet containing S. boulardii (20 MLD/bst) to be dispersed in the Simeticone emulsion at first use;
- Indicated in the treatment and prevention in dyspeptic disorders, gastrointestinal bloating, aerophagia and gas colic caused by intestinal dysbiosis, to decrease the surface tension of the enteric lumen and to restore intestinal flora;
- Preservative-free;
- Bubble-Burster: Enhanced antifoaming activity compared with aqueous emulsion;
- Patent-protected formulation.
All versions are free of Sugar, Gluten, Lactose and Alcohol.
