Medical Mouthpieces of Type IIR in box of 50 pcs. (CE marked)

Instructions:

1. Wash hands thoroughly before use.
2. Place the mask with the nose clip against the nose and then adjust the mask.
3. Place the ear cords behind the ears.
4. Be sure to cover the face tightly around the nose, chin and cheeks.

Intended use:

Prevent the spread of infectious respiration, coughing and sneezing. Protection against inhalation of airborne particles such as dust, pollen and transmissible bacteria and viruses. Advarsel:

• Check that the product is sealed before use.
• Do not use if inner packaging is open.
• Children should only wear the mask with the help of an adult.

 

What is CE marking ?:

The CE mark indicates that the equipment complies with medical device legislation. In order to CE mark medical equipment, the manufacturer must document the product's quality, safety and performance. read more on The Danish Medicines Agency's website

The Danish Medicines Agency on bandages:

When you buy bandages that are medical equipment, they must be CE-marked like all other medical equipment, and there must be a user manual in Danish. Mouthpieces, which are classified as medical devices, are often white and blue three-layer mouthpieces with bandages or ear elastics and are intended for single use.

The Danish Medicines Agency's technical requirements

Depending on the filtering ability, they can be called type I, type II or type IIR. The package must clearly state who the manufacturer is. That is, who makes the equipment and is responsible for ensuring that it meets current requirements. The label must also contain information that can identify the exact product, including a so-called reference number and a LOT number. Finally, if the manufacturer of the sanitary napkin is located outside the EU, then the product must be provided with an indication of who is the manufacturer's representative within the EU. Read more about bandages directly on the Danish Medicines Agency's website here. This box with "Medical Mouthpieces of Type IIR in box of 50 pieces" complies with all these requirements and guidelines.  

Important articles from the National Board of Health:

• 15 August 2020: Requirements for bandages in public transport and special recommendations for people at increased risk