DEOMED medical socks - medical device

DEOMED® medical socks are a fully-fledged medical device meeting the strict requirements set out in Polish and European law. Polish regulations take a very strict approach to medical devices. Only a product that meets all safety requirements adopted by the EU may be placed on the market.

Under the Act of 20 May 2010 on medical devices, a product must undergo a conformity assessment procedure under that act before it can be placed on the market. It should also have an EC Declaration of Conformity and the CE mark on the label. The complicated process of registering a medical device with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) discourages many manufacturers from taking such action. Why is medical device status so important?

Why is medical device status so important?

Using the legal pathway that gives a product medical device status attests to its high usefulness in supporting treatment. Before first placing a product on the market, the manufacturer must go through a long and arduous process of notification and registration. The first stage involves a Clinical Evaluation and conformity assessment procedure. This must be clear confirmation that the product meets all essential requirements described in the medical devices act. Every medical device must have understandable instructions for use in Polish or using symbols that leave no doubt. The final stage is formal notification of the device to URPL, as a result of which it is registered in the URPL medical devices database and gains the right to be placed on the EU market after 14 days.

What advantage does a medical device have over uncertified products?

The complex process of obtaining medical device status discourages many manufacturers from engaging in such activity. Registering each product separately involves, among other things, adapting the goods to the highest safety standards. Hence on the market of products intended for medical prevention or rehabilitation one can find many items described as "healing", "for health" or "comfortable". These claims, if not backed by real official documents, are worth little. Polish law does not provide penalties for naming products in this way. However, it is worth remembering that such goods are often not controlled, checked or verified in any way for medical usefulness. Manufacturers who do not want a product to obtain medical device status may not fully care about real treatment-supporting properties. Moreover, they have no such legal obligation. This means that a customer facing a genuine medical device bearing the CE mark obtains full assurance of the authenticity and usefulness of the product.

DEOMED® medical socks – a medical device. What strict requirements does the product meet?

DEOMED® medical socks, as an officially verified medical device, meet a range of high quality requirements. In addition to complying with legal aspects, the DEOMED® sock manufacturer has a set of tools that increase product quality and effectiveness for human health. The manufacturer holds specialist Clinical Evaluations prepared by specialist doctors, including in diabetology. Five Clinical Evaluations have been developed concerning specific DEOMED® sock models. The medical device has been placed in the first safety class relating to the safest medical devices for humans, meaning it is a product that meets all requirements regarding safe use. All DEOMED® medical sock models bear the CE mark, reflecting compliance with current legal requirements for medical devices. Thanks to detailed safety procedures, since the company was founded no medical incidents have been recorded in connection with use of the company's products.

Health parameters of DEOMED® socks. How do they affect human health?

DEOMED® medical socks are intended for preventive use during many diseases. Their use is recommended, among others, in diabetes, as they significantly help reduce the risk of the so-called diabetic foot syndrome. The product can also be used when struggling with leg circulation problems. The medical device fits the lower limb without restricting blood flow to tissues in any way. Specialists recommend seamless socks for various bone diseases, e.g. related to foot deformity, degenerative changes or after injuries. The product is also recommended for recurring fungal and atopic problems causing inflammation, unpleasant itching and pain when walking. Using the socks increases patient comfort, provides relief when walking, enables proper air circulation and reduces the risk of worsening disease symptoms.

Product characteristics. What distinguishes medical socks?

This is a product worn directly on the foot that, thanks to appropriate construction, does not compress the limb. Most DEOMED® socks are seamlessly joined over the toes; terry socks have a flat seam of small thickness, thinner than the sock fabric, that does not affect wearing comfort. Medical socks prevent chafing, scratches and blisters. They have a special cuff construction that gently adheres to the skin without impeding flow of body fluids. Thanks to elastic properties they can be worn by people with swollen legs, e.g. in diabetes. The product has antimicrobial action, which helps reduce the risk of bacterial or fungal foot infections.

Types of DEOMED® socks. What does the manufacturer offer?

Nine models of DEOMED® socks and knee-highs with medical device status are currently registered. Each type has a slightly different specification and is aimed at specific patient needs. All products listed below meet the highest safety and usability standards. They help reduce the intensity of unpleasant disease symptoms, prevent infections and improve user quality of life. The DEOMED® sock collection includes:

• Deomed® Cotton Silver – thin cotton socks with silver ions. They have antifungal and antibacterial action.
• Deomed® Bamboo – thin socks made from soft, pleasant yet strong bamboo yarn.
• Deomed® Wool – thin socks with merino wool.
• Deomed® Wool Long – thin knee-highs with merino wool.
• Smart Seacell – thin socks containing antimicrobial zinc and a caring extract from seaweed.
• Medic Deo Cotton – thick cotton socks with Sanitized antimicrobial finish.
• Medic Deo Silverwool – warm terry socks with merino wool and silver ions.
• Deomed® Bamboo Long – thin bamboo yarn knee-highs.
• Medic Deo Long – thick cotton terry knee-highs with Sanitized antimicrobial finish.

Conditions in which use of DEOMED® medical socks is recommended

• Diabetes. The socks reduce the risk of diabetic foot syndrome. They do not compress tissues as ordinary socks do.
• Overweight and obesity. People struggling with excess weight are more prone to foot overload. Poorly chosen socks increase the risk of chafing, wounds and calluses.
• Limb deformities. The medical device increases patient quality of life and reduces pain and discomfort related to wearing uncomfortable socks.
• Fungal and inflammatory foot conditions. Antibacterial socks let feet breathe freely while limiting multiplication of fungi and bacteria.
• Problems with sweating. Airy, breathable DEOMED® socks reduce problems related to excessive sweat production. They lower the risk of infections or inflammatory conditions linked to growth of pathogens.

International reputation of DEOMED® socks. Review of major awards

DEOMED® medical devices have so far received more than a dozen awards at prestigious trade fairs and medical competitions. Major distinctions include first prizes in the preventive clothing category, won repeatedly for several years at Diabetica Expo (the last award in 2019). DEOMED® socks were also honoured at the Natural Medicine Fair, International Rehabilitation Equipment Fair and the readers' poll of "PEN Diabetes and Obesity". The company's consistent efforts aimed at constantly raising quality standards underpin the success of its medical products. DEOMED® socks also have an official recommendation from the Polish Diabetes Association. Annual awards and distinctions are credible confirmation of the effectiveness and highest quality of DEOMED® brand products.

DEOMED® socks are exported to many countries known for high quality requirements, such as Germany and Scandinavian countries.

Important! Deomed® products are registered as medical devices, which does not mean they treat specific conditions. They may be used in the prevention of various conditions, may help prevent their onset and relieve symptoms associated with those conditions. Articles published on our blog are for informational purposes and draw attention to possible medical issues, but they do not relate to specific health cases and should not be used as medical knowledge or medical advice. All medical matters should be discussed with an appropriate doctor.