Nasal Kit MDD-Certified: MDR Transition Extended

MDR Transition Extended Beyond 2024: Ongoing Market Access for Our Nasal Kits

The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices across Europe. Thanks to the extended transition timelines, devices compliant with the MDD Directive can remain on the market until December 31, 2027, for Class III and implantable Class IIb devices, and until December 31, 2028, for Class IIb, IIa, and Class I devices.

We have successfully obtained the extension of the MDR transitional period beyond May 26, 202,4, for our legacy Class I, IIa, and III devices. This confirms our ongoing MDR compliance through formal application for certification with our Notified Body. Furthermore, we have signed a contract with the Notified Body to ensure continuous market presence and regular surveillance for each legacy device.

Our Nasal Kits for Daily Hygiene and Airway Health

We have secured the MDD certification extension for all our nasal irrigation and nebulization kits. These medical devices are designed for cleansing and hydrating the nasal cavities and are indicated for colds, allergic and non-allergic rhinitis, rhinosinusitis, nasal congestion, and in some cases, for the prevention of otitis media. Administration is achieved via direct nasal irrigation or inhalation therapy using the included nasal nebulizer, even without the use of electro-medical equipment.

Three Formulations for Different Needs

• RINOFAST ISO KIT – Daily Hygiene and Prevention

An isotonic solution based on sodium chloride and sodium bicarbonate. Ideal for daily nasal hygiene, it helps clear the nasal passages in case of colds, rhinitis, sinusitis, or whenever decongestion is needed or mucociliary transport is impaired. Also suitable for preventing otitis media by improving upper airway ventilation. The kit includes 15 resealable 5 ml single-dose vials and a nasal nebulizer.

• ALIPER KIT – With High Molecular Weight Hyaluronic Acid

A preservative-free hypertonic formula enriched with hyaluronic acid, 3% sodium chloride, and bicarbonate. Especially recommended for rhinitis (allergic and non-allergic), rhinosinusitis, and otitis media. Thanks to the included nebulizer, it can be administered to young children who cannot tolerate electro-medical nasal showers. It helps reduce nasal discharge, improves breathing, and prevents recurrent infections.

• RINOFAST AEROSOL KIT – Effective Nasal Relief

A 3% sodium chloride hypertonic solution is ideal for relieving nasal congestion and cold symptoms. Its osmotic action promotes mucus fluidization and removal, restoring mucociliary clearance and moisturizing the nasal mucosa. It can be administered via direct irrigation or inhalation, making it practical even without special equipment. Suitable for both children and adults.

Partner with Us to Develop Effective Respiratory Solutions

We are specialized manufacturers of medical devices. Thanks to our in-house expertise, we offer market-ready products and create customized formulations under private label or contract manufacturing. Innovation, quality, and safety are at the heart of our work, delivering effective and tailored solutions.

If you’re interested in becoming a private label or out-licensing partner: