La Pointique Int´l Ltd.

La Pointique Int'l Ltd. specializes in orthopedic supports, including ankle wraps, elbow supports, knee braces, and compression sleeves. Their product line also covers specialized items like the COOLPRENE X Knee Support, COOLPRENE Back Support with extra lumbar reinforcement, magnetic waist supports, and protective shields for joints such as the Light Shield Knee Brace. These devices are designed to provide support, compression, or protection for musculoskeletal conditions.

La Pointique Int'l Ltd. is based in the United States. While the company’s location determines its primary regulatory jurisdiction (e.g., FDA in the US), its devices listed in eudamed indicate they are also intended for the European market. The EU’s eudamed registry ensures these products comply with European medical device regulations, even if the manufacturer is not based in the EU.

Devices from La Pointique Int'l Ltd. are listed in the eudamed registry, which is the EU’s central database for medical devices. Listing in eudamed is required for devices placed on the European market, as it demonstrates compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). This registry helps healthcare professionals, regulators, and authorities verify the legitimacy and regulatory status of the devices.

All devices manufactured by La Pointique Int'l Ltd. fall under Class I regulatory classification. This classification applies to low-risk devices like orthopedic supports, wraps, and compression sleeves, which typically pose minimal risk to patients. Class I devices often require less stringent regulatory oversight compared to higher-risk classes, but they still must meet basic safety and performance requirements to ensure safe use.