Medical device with hyaluronic acid and natural actives to relieve dryness, itching, irritation, and intimate infections We are proud to announce that our vaginal ovule, a Class IIa medical device, has been officially registered with the Cabinet of Ministers of Ukraine. This milestone confirms the safety and effectiveness of our formula, developed to meet the…
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…
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…
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…
Treatment for Vulvovaginal Mycotic Infections: FarmaImpresa Group certifies a new Medical Device in Macedonia We have completed the registration with the competent authorities in Macedonia for a Class I medical device, designed for the treatment of vulvovaginal mycotic infections. The medical device is formulated as a vaginal suppository based on hyaluronic acid, boric acid, and…
Clinical study: Vaginal ovules containing hyaluronic acid, polycarbophil and lactic acid for vulvovaginal symptoms such as burning, dryness, irritation, dysuria and dyspareunia Gruppo FarmaImpresa is required, for regulatory reasons, to regularly follow a postmarketing surveillance system called postmarketing clinical follow-up (PMCF). The PMCF is a continuous and proactive process that aims to continuously evaluate the…