GFI Extends MDD Certification for Vaginal Douches

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 III and implantable class IIb devices, and until December 31, 2028, for other class IIb, IIa, and I devices. Manufacturers must possess a declaration and a “confirmation letter” from the notified body to ensure market continuity during the transition.

We have secured extensions for the MDR transitional period beyond May 26, 2024, for our legacy class I, IIa, and III devices, confirming MDR compliance through certification applications to the notified body. Additionally, we have signed a contract with the notified body and are committed to maintaining compliance with Directive 93/42/EEC and conducting regular surveillance for each legacy device.

In March 2024, we achieved a significant milestone: the extension of the MDD certificate for all our vaginal douches (Lattawin, Ginox, Revaginal, and Ginclor). This highlights our constant commitment to the quality and safety of medical devices designed for intimate female wellness.

With four specific formulations, our vaginal douches provide targeted solutions for women’s needs at different stages of life, thanks to active ingredients that work synergistically to ensure efficacy and comfort.

Our Formulations: Tailored Action

Our four vaginal douche formulations combine natural and scientifically tested active ingredients, offering personalized solutions for women’s diverse needs:

• Lattawin Vaginal Douche: Formulated with boric acid, lactic acid, aloe barbadensis, and melaleuca alternifolia, it is ideal for balancing vaginal pH and preventing yeast and bacterial infections.
• Ginox Vaginal Douche: With hyaluronic acid, lactic acid, and hydrogen peroxide (H₂O₂), it is perfect for combating vaginal dryness, promoting hydration and elasticity.
• Revaginal Vaginal Douche: Featuring hyaluronic acid, lactic acid, and PVP, it is designed to protect and regenerate the vaginal mucosa, reducing irritation and discomfort.
• Ginclor Vaginal Douche: This is a complete combination of boric acid, lactic acid, aloe, chlorhexidine, and tea tree oil, ideal for treating mixed infections and persistent irritations.

The Benefits of Vaginal Douches

Thanks to the synergy of active ingredients, our vaginal douches are medical devices useful for:

• Relieving vaginal itching, burning, and irritation.
• Restoring the natural vaginal pH.
• Addressing vaginal dryness.
• Treating mixed vulvovaginitis and supporting the recovery of natural vaginal conditions.

Support for Every Stage of Life

Our four vaginal douche formulations (Lattawin, Ginox, Revaginal, and Ginclor), which combine active ingredients such as boric acid, lactic acid, and tea tree oil, scientifically recognized for their benefits, meet the needs of women at different stages of life:

• Post-pubertal adolescents: To manage the body’s first changes.
• Adult women: For maintaining daily intimate wellness.
• Postmenopausal women: To alleviate discomfort associated with dryness and pH imbalances.

Why Choose Our Vaginal Douches?

Intimate health is essential for overall well-being. Our vaginal douches not only relieve common discomforts but also help restore and maintain the natural balance of vaginal flora.

Discover our formulations and become our distributor!