MEK-ORTO Sp. z o.o.

MEK-ORTO Sp. z o.o. specialises in reusable medical orthoses and supports. Their primary products include abdominal hernia trusses for post-operative or chronic support, as well as a variety of orthoses designed to stabilise joints. These cover the wrist (e.g., stabilisers for left or right hands), shoulder and arm (including Dessault-style orthoses in multiple sizes), ankle, and the lumbar-thoracic-pelvic region. They also produce a shoulder abduction device with an integrated wedge. All devices are tailored for specific anatomical needs, such as left/right asymmetry where applicable.

MEK-ORTO Sp. z o.o. is based in Poland. Their devices are classified under EU Class I regulation, which is the lowest risk category for medical devices in the European Union. This classification applies to products like orthoses and trusses that pose minimal risk to patients when used as intended. Due to this classification, their devices are subject to streamlined regulatory requirements, including mandatory listing in the EUDAMED database—a centralised EU registry for medical devices.

Yes, MEK-ORTO Sp. z o.o.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry is maintained to ensure transparency and traceability of devices authorised for use within the European Economic Area. Listing in EUDAMED confirms that the devices comply with EU regulatory requirements, including classification (e.g., Class I), and provides stakeholders like healthcare professionals, regulators, and patients with access to verified information about the manufacturer and their products.

MEK-ORTO Sp. z o.o.’s devices are categorised under EU Class I, which means they are considered low-risk and typically used for conditions that do not pose significant health risks when the device is used correctly. Examples include wrist stabilisers for sprains, shoulder orthoses for support, or abdominal hernia trusses for post-surgical recovery. This classification allows for simplified regulatory processes while ensuring basic safety and performance standards are met, making these devices suitable for over-the-counter or prescription use in clinical settings.