Proctology Line MDR certified

Our proctology products are now available in a private label model as Class IIb medical devices compliant with the MDR.

Our portfolio includes:

• Rectal suppositories supporting mucosal regeneration,• Rectal gel with applicator,
• Solutions intended for use in hemorrhoids, anal fissures, irritation, and after proctology procedures.

We provide comprehensive services: product development, production, MDR documentation, and packaging preparation for the client's brand.

Rectal suppositories supporting mucosal regeneration The rectal suppositories have been developed for the local protection, moisturisation and support of the natural regeneration of the anal canal mucosa. After application, they form a protective layer on the mucosal surface, helping to reduce further irritation and creating favourable conditions for tissue recovery.

The device may be used as an adjunct in cases of haemorrhoids, anal fissures, irritation, burning, itching and discomfort associated with damaged or dry mucosa. The formulation may also be used following proctological procedures, when protection of the treated area and support of the healing process are particularly important.

The suppository dosage form enables precise local delivery of the ingredients into the anal canal. After melting, the product evenly coats the mucosa and remains in direct contact with the irritated area.

The product is available as a private-label Class IIb medical device compliant with the EU MDR. The trade name, packaging design, pack size and product information materials may be adapted to the customer’s brand and target market.

Rectal suppositories with sucralfate Rectal suppositories with sucralfate are a specialised solution intended to protect and support the regeneration of damaged or irritated rectal mucosa.

Sucralfate adheres to the surface of irritated or damaged tissue and forms a local protective barrier. This barrier helps shield sensitive areas from irritants such as faecal matter, moisture and mechanical friction. As a result, the device may help reduce discomfort and support the natural restoration of the mucosa.

The product may be used as an adjunct in cases of:

internal haemorrhoids, anal fissures, irritation and minor mucosal damage, burning, itching and discomfort, recovery following proctological procedures. The suppository form enables local action within the anal canal and prolonged contact of the formulation with the mucosal surface. This is particularly important for products based on a physical protective mechanism of action.

The device is available as a private-label Class IIb medical device compliant with the EU MDR. It may be offered as a standalone product or as part of a complete proctology range together with a rectal gel.

Rectal suppositories with hyaluronic acid Rectal suppositories with hyaluronic acid have been developed to provide intensive moisturisation, protection and support for the regeneration of the rectal mucosa.

Hyaluronic acid has a high water-binding capacity and helps maintain an appropriate level of tissue hydration. It also forms a delicate protective layer on the mucosal surface, helping to reduce friction and further irritation.

The device may be used as an adjunct in cases of mucosal dryness, irritation, minor injuries, haemorrhoids and anal fissures, as well as during recovery following proctological procedures. Improved hydration of the mucosa may help reduce discomfort during bowel movements and protect particularly sensitive tissues.

The suppositories are convenient to use and allow gradual release of the ingredients at the site of application. Depending on the final product concept, the formulation may also be supplemented with additional protective, soothing or regenerative ingredients.

The product may be developed under the customer’s brand as a Class IIb medical device, with full adaptation of the packaging, number of suppositories per pack and product communication to the target market.

Rectal gel with applicator The rectal gel is intended to protect, moisturise and support the regeneration of the rectal mucosa and the skin around the anus. Its carefully selected consistency allows the product to spread easily over the tissue surface and form an even protective layer.

The supplied applicator enables convenient and precise administration both into the anal canal and onto the external perianal area. This allows the product to be used for both internal and external symptoms.

The gel may be used as an adjunct in cases of:

internal and external haemorrhoids, anal fissures, irritation and abrasions, burning, itching and discomfort, dryness of the mucosa, conditions requiring protection following proctological procedures. The gel formulation provides local action and good contact with the mucosal surface. It may help reduce friction, improve hydration and support the natural regeneration of irritated tissues.

The product may be supplied in a multidose tube with an applicator or in single-dose containers, depending on the customer’s requirements and the target market.

Rectal gel with sucralfate The rectal gel with sucralfate has been developed as an advanced protective medical device intended for use within the anal canal and on the external pe...