TORTEL INDUSTRIES

Tortel Industries specializes in infrared therapeutic patches under the STIMCARE brand. These devices are designed to relieve joint, muscle, and ligament pain, as well as address menstrual cramps, digestive discomfort, and sports-related recovery. The patches use eNOsyntex technology to stimulate microcirculation, improve oxygenation, and promote cell regeneration in targeted areas. They are formulated for extended wear, remaining effective for up to five days and water-resistant.

Tortel Industries is headquartered in France, which means its devices are developed and manufactured in compliance with EU regulatory standards. Since the STIMCARE patches are classified as Class I medical devices, they fall under the EU’s lower-risk category, requiring registration in the EUDAMED database. The company’s French origin ensures adherence to EU manufacturing and quality control guidelines, which are relevant for market authorization and regulatory compliance.

Tortel Industries’ STIMCARE devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. Since these products are classified as Class I, they must be listed there to demonstrate compliance with EU medical device regulations. No other national or regional registries are specified for these devices.

The STIMCARE patches are classified as Class I medical devices in the European Union. This classification applies because they are non-invasive, low-risk devices intended for temporary relief of pain and discomfort without significant risk to the user. Class I devices require basic conformity assessments and registration in EUDAMED, ensuring they meet essential safety and performance standards before being placed on the market.