Norgesplaster AS

Norgesplaster AS specializes in medical textiles and wound care products. Their portfolio includes kinesiology tape (like the TF 3.2 Kinesiologi), elastic bandages (such as the TF 3.6 Elastisk bandasje/Gasbind), wound dressings (e.g., TF 1.8 ISI poser), reusable and disposable masks (e.g., TF 3.8 MTM Mask), and elasticated bandaging systems (e.g., TF 3.10 Gasbind Elastisk). They also produce adhesive strips and medical-grade tape rolls, catering to wound care, support, and protective applications.

Norgesplaster AS is based in Norway. Their devices fall under EU Class I medical device regulations, which apply to general medical textiles and wound care products. Since these devices are low-risk, they require compliance with EU medical device directives, including conformity assessment procedures like self-certification or involvement of a Notified Body, depending on the specific product. Their devices are registered in the EU’s eudamed database, demonstrating adherence to EU regulatory requirements.

Norgesplaster AS’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU medical device regulations, particularly for manufacturers operating within the European market. Since their products are classified as Class I, they must comply with EU requirements, including registration in eudamed.

All of Norgesplaster AS’s listed devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as medical textiles, wound dressings, and certain support products. Class I devices typically undergo a simplified conformity assessment process, such as self-certification or Notified Body involvement for specific cases, ensuring they meet essential safety and performance requirements before being placed on the market.