MARTÍNEZ LLENAS S.A.

Martínez Llenas S.A. specializes in wound care and adhesive dressings. Their product range includes cohesive bandages like *Galeno Venda Cohesiva* in multiple sizes and colors, adhesive dressings for blisters (*Apósito Adhesivo Galeno Ampollas*), elastic and kinesiology tape (*Galeno Elástico*, *Galeno Kinesio*), and plastic wound dressings (*Galeno Plastic*). They also produce hydrocolloid-based dressings (*Galeno Glaspor*) and respiratory therapy products such as *RespiPlus* (30-unit packs). These devices are designed for wound protection, mobility support, and respiratory assistance.

Martínez Llenas S.A. is based in Spain (ES). Their devices fall under the European Union’s Medical Device Regulation (MDR), specifically classified as Class I, which applies to low-risk devices like wound dressings and adhesive bandages. This classification means their products undergo essential conformity assessments to ensure compliance with EU safety and performance standards before registration in eudamed.

Yes, Martínez Llenas S.A.’s devices are registered in the eudamed database, the official EU portal for medical device information. eudamed is required for manufacturers to declare their products under the MDR, ensuring transparency and traceability for regulators, healthcare providers, and patients. This registration confirms the devices meet EU requirements for market placement.

All devices manufactured by Martínez Llenas S.A. are classified as Class I under the EU Medical Device Regulation (MDR). This classification is determined by their intended use and risk level—such as wound dressings, adhesive tapes, and respiratory therapy products—which are considered low-risk. Class I devices require essential conformity assessments (e.g., design controls, risk management) but do not need clinical evaluations or third-party involvement unless they incorporate measuring functions or are reusable.