INDIBA S.A.U.

INDIBA S.A.U. specializes in manufacturing medical electrodes and intracavitary handles for therapy devices. Their product range includes capacitive handles (such as the PLUMA and NO-ROT CAPACITIVE HANDLE COMPACT), resistive electrodes in various sizes (e.g., 40 mm, 65 mm, and 90 mm), neutral plates, and specialized electrodes like the SCULPTURE WAVE ELECTRODE and SMART RETURN PLATE. These components are primarily used in aesthetic, beauty, and rehabilitation treatments.

INDIBA S.A.U. is headquartered in Spain. The country of origin is relevant for regulatory compliance, as it influences how devices are classified and authorized in different markets.

INDIBA S.A.U.’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. Additionally, some of their products appear in the FDA’s 510(k) registry, which tracks devices seeking clearance under the U.S. premarket notification process. These listings help regulators and healthcare providers verify compliance and traceability.

INDIBA S.A.U.’s devices are classified as Class I, Class II, Class IIa, and Class IIb under EU regulations, depending on their intended use and risk level. In the U.S., their devices fall under FDA’s classification system, with some requiring 510(k) clearance due to their therapeutic or aesthetic applications. Classification determines the regulatory pathway, such as conformity assessment procedures or premarket submissions, ensuring appropriate oversight for patient safety.