Unigroup ApS

Unigroup ApS specializes in topical dermatological treatments and devices for localized skin care. Their portfolio includes products like liquid solutions (e.g., wart treatments), gels (e.g., for skin tags or fungal nail infections), adhesive patches, and applicator pens (e.g., for nail fungus). These are designed to address common dermatological concerns such as warts, fibromas, papillomas, and fungal nail infections.

Unigroup ApS is based in Denmark. Their devices are developed in accordance with the EU Medical Device Regulations, ensuring compliance with European Union requirements for safety, performance, and regulatory transparency. This includes mandatory registration in the EUDAMED database, which tracks all relevant medical devices within the EU.

Unigroup ApS’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. This registry ensures transparency and allows stakeholders—such as healthcare professionals, regulators, and patients—to verify the presence of their products under EU regulatory oversight.

Unigroup ApS’s devices fall under Class I and Class IIa classifications according to the EU Medical Device Regulations. The classification depends on factors like the intended use, risk level, and interaction with the body. For example, low-risk treatments like adhesive patches or non-invasive topical gels are typically Class I, while slightly higher-risk products (e.g., those requiring more precise application or potential skin irritation) may be Class IIa.