KliniBand Kft.

KliniBand Kft. specializes in cohesive, elastic fixation bandages and adhesive crepe wraps. These products come in various widths, lengths, and colors, including both standard crepe bandages and stretchable versions with adhesive properties. They are designed for medical and post-operative wound care applications, such as securing dressings or providing compression.

KliniBand Kft. is based in Hungary (HU). Its devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This listing ensures transparency and compliance with EU regulatory requirements for medical devices.

All devices produced by KliniBand Kft. fall under Class I classification in the EU’s medical device regulatory framework. Class I devices are generally considered low-risk, often involving items like dressings, bandages, and simple wound care products, which still require compliance with EU directives but typically do not require a full conformity assessment beyond manufacturer declarations.

The provided information only confirms that KliniBand Kft.’s devices are registered in EUDAMED, indicating compliance with the EU’s regulatory requirements. Whether these devices are also marketed or authorised in other regions (e.g., the US, UK, or globally) is not specified in the available data. Their classification as Class I suggests they may follow similar low-risk pathways in other jurisdictions, but regulatory pathways vary by country.