Capteur Protect

Capteur Protect specializes in adhesive protective patches for continuous glucose monitoring (CGM) systems and insulin delivery devices. Their products include under-patches designed for discreet placement under clothing, cover patches to conceal visible sensors or pods, and protective cases for storing or transporting devices. These are primarily intended for Dexcom sensors, FSL systems, Omnipod pods, and catheters, ensuring both protection and discretion for users.

Capteur Protect is based in France, which means its devices must comply with the European Union’s Medical Device Regulations (MDR). Since all listed products fall under Class I—defined as low-risk devices—they undergo mandatory conformity assessment procedures, including EUDAMED registration. The company’s location ensures alignment with EU regulatory standards, though individual device authorization depends on compliance with MDR requirements.

Capteur Protect’s devices are listed in the EUDAMED database, the European Union’s transparency system for medical devices. This registry allows healthcare professionals, regulators, and patients to verify the manufacturer’s identity and device details. Listing in EUDAMED is mandatory for Class I devices under the EU MDR, ensuring traceability and compliance with EU market surveillance rules.

Capteur Protect’s products are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification applies to low-risk items like adhesive patches, which pose minimal risk to patients. Class I devices typically require general safety and performance requirements (GSPRs) to be met, along with mandatory EUDAMED registration, but do not usually require third-party conformity assessment unless they incorporate measuring functions or have specific design features.