MDD Certification: Vaginal Ovules for Intimate Well-Being

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

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

With seven specific formulations, our vaginal ovules provide targeted solutions for various gynecological needs, supporting vaginal health in delicate moments such as postpartum recovery, menopause, or after an infection.

Who Are Vaginal Ovules Recommended For?

Our ovules are designed to support women at every stage of life, offering effective solutions for common gynecological issues.

After Childbirth, Surgery, or Chemotherapy

The vaginal mucosa can become irritated and more sensitive after childbirth, gynecological surgery, or cancer treatments. Our ovules promote recovery and help restore pH balance, relieving dryness and irritation.

For Menopause and Vaginal Dryness

As estrogen levels decrease, the skin and mucous membranes become more fragile, leading to discomfort such as dryness, pain during intercourse, and a higher risk of infections. Our vaginal ovules help restore optimal hydration, improving daily comfort.

To Counteract Acute or Recurrent Vaginal Infections

Candida, bacterial vaginosis, and other vaginal infections can cause burning, itching, and abnormal discharge. Our formulations with boric acid and tea tree oil help restore the vaginal microbiota and prevent the proliferation of pathogens.

After Antibiotic Therapy or in Case of Dysbiosis

Antibiotic treatments or hormonal imbalances can disrupt the vaginal flora, increasing the risk of infections. Our vaginal ovules, enriched with probiotics and balancing ingredients, help restore the natural equilibrium of the mucosa.

Formulations Designed for Intimate Well-Being

Every woman has different needs, which is why we have developed seven specific formulations, each enriched with targeted ingredients:

• CAREGYN OVULES – Boric acid, hyaluronic acid, tea tree oil, glycyrrhetic acid, lactic acid, vitamins A and E.
• GINOX OVULES – Carbamide peroxide, boric acid, lactic acid, glycyrrhetic acid, vitamins A and E, tea tree oil.
• GINCLOR OVULES – Chlorhexidine, boric acid, hyaluronic acid, lactic acid, tea tree oil.
• TALAVEA OVULES – Aloe vera, sage, lactic acid, tea tree oil, vitamin E, 18-beta glycyrrhetic acid.
• REVAGINAL OVULES – Hyaluronic acid, tea tree oil, lactic acid, glycyrrhetic acid, vitamins A and E.
• LATTAWIN OVULES – Boric acid, lactic acid, glycyrrhetic acid, vitamins A and E, tea tree oil.
• CAMOGYN OVULES – Hyaluronic acid, centella asiatica extract, calendula officinalis extract, chamomile recutita extract, melaleuca essential oil.

Each active ingredient has been carefully selected to address specific intimate health needs:

• Regeneration and hydration → Hyaluronic acid and vitamins A and E help restore and maintain the elasticity and hydration of the vaginal mucosa.
• Balance and protection → Lactic acid, boric acid, and polycarbophil help maintain physiological pH and rebalance the vaginal flora.
• Soothing and anti-inflammatory action → Glycyrrhetic acid, aloe vera, and sage are calming, reducing irritation and redness.
• Defense and purification → Tea tree oil, chlorhexidine, and carbamide peroxide help prevent the growth of pathogenic microorganisms, protecting against infections.

By combining these active ingredients, our vaginal ovules promote the restoration of vaginal flora, prevent infections, and relieve discomfort such as irritation, itching, and dryness.

Why Choose Our Vaginal Ovules?

✔ Formulations with synergistic ingredients for targeted support.

✔ Effective solutions for dryness, irritation, dysbiosis, and infections.

✔ MDD certification ensuring safety and quality.

✔ Dermatologically tested for safe and gentle use.

Thanks to MDD certification, our vaginal ovules are a safe and effective choice for intimate well-being, offering concrete support when needed most.

In addition to offering a line of MDD-certified vaginal ovules, we are specialized manufacturers of medical devices with extensive experience in developing solutions for women’s intimate health. Thanks to our in-house expertise, we provide ready-to-market products and create customized formulations under private labels, meeting each client’s specific needs. Innovation, quality, and safety are at the core of our work, ensuring effective and tailored solutions.

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