Gruppo FarmaImpresa at the Top of European Quality: Maximum Safety for Gynecologic Well-Being The EU Regulation 2017/745 (MDR) is Europe’s most stringent framework for manufacturing and marketing medical devices. It raises the bar on safety, quality, and traceability, introducing far stricter requirements than previous directives. For Gruppo FarmaImpresa, obtaining MDR certification for the Class IIb…
Clinically Proven Effectiveness of Our Hyaluronic Acid-Based Vaginal Medical Device for Women’s Intimate Health Gruppo FarmaImpresa is proud to share the results of its clinical study, conducted on the medical device Revaginal Ovules. The study evaluated the safety and effectiveness of our vaginal ovules in promoting vaginal and uterine tissue regeneration, offering an innovative and…
Medical device based on 3% Boric Acid for the treatment of vaginal infections and dryness: results after 4 weeks of treatment Vaginal infections, particularly those caused by Candida albicans, represent one of the main causes of intimate discomfort in women, with recurrent episodes that significantly affect daily well-being and quality of life. To meet this…
Fertility support with a biocompatible and clinically tested formulation From 2022, our vaginal gel is officially registered in cambodia. This important recognition confirms the safety and effectiveness of a formulation designed to support natural conception in a simple, targeted, and physiologically respectful way. This medical device was developed to create an optimal vaginal environment for…
MDD Certified Vaginal Tablets for Intimate Health The Medical Device Regulation (MDR), in effect since May 2017 and fully applicable from May 2021, regulates medical devices in Europe. Thanks to deadline extensions, devices compliant with the MDD Directive can continue to be marketed until December 31, 2027, for Class III and implantable Class IIb devices,…
MDD Certification for Our Vaginal Ovules: A New Milestone for Intimate Health The MDR Regulation, in force since May 2017 and applicable from May 2021, governs European medical devices. Deadline extensions allow medical devices compliant with the Medical Device Directive (MDD) to be marketed until December 31, 2027, for Class III and implantable Class IIb…
Vaginal Gel: Registered Medical Device in UK for Women’s Intimate Well-Being We are pleased to announce the official registration with the relevant authorities in the UK of a Class II medical device, compliant with MDD regulations. This is a vaginal gel with a pH of 4.5, packaged in practical 5 ml tubes (6 tubes per…
Extension of the MDD Certificate for Our Medical Devices Supporting Women’s Wellness at Every Stage of Life The MDR Regulation, in effect since May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Device Directive (MDD) until December 31, 2027, for class…
Registration of a Medical Device in Oman: Vaginal Suppositories Based on Hyaluronic Acid, Lactic Acid, Triglycerides, and Polycarbophil We are pleased to announce the recent registration of a Class II medical device with the competent authorities in Oman. This milestone reflects our ongoing commitment to providing women’s health solutions in compliance with international standards. …
Effective vaginal relief: medical device registered in Vietnam for women’s well-being GFI proudly announces that we have successfully registered a Class IIa medical device in Vietnam, formulated with natural ingredients. This device is a vaginal ovule composed of hyaluronic acid, lactic acid, Centella Asiatica, calendula, chamomile, and tea tree oil. Indicated to addressing a wide…