ARMEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

ARmedical produces a variety of reusable medical devices primarily focused on orthopedic support and mobility aids. These include ankle and foot orthoses (both high and low), non-foldable walking chairs, reusable hot/cold therapy packs, and a range of orthopedic supports such as shoulder/arm slings, finger stabilizers, Schantz-style cervical collars, spinal braces (for lumbar-sacral and torso support), and inguinal hernia belts. The company’s portfolio is designed to assist in rehabilitation, pain management, and mobility support.

ARmedical is based in Poland, which means its devices are subject to EU Medical Device Regulation (MDR) requirements. Since all listed devices fall under Class I classification, they must comply with MDR standards, including registration in the EUDAMED database. The company’s location in Poland allows it to participate in the EU’s medical device market while adhering to centralized regulatory frameworks.

Yes, ARmedical’s devices are registered in the EUDAMED database, which is the European Union’s official registry for medical devices. This listing ensures transparency and traceability, allowing healthcare professionals, regulators, and patients to verify the device’s compliance with EU medical device regulations. For Class I devices, EUDAMED registration confirms that the manufacturer has met the necessary requirements for market placement under the MDR.

All of ARmedical’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices that pose minimal risk to patients and users, such as orthopedic supports, therapy packs, and mobility aids. Class I devices still require compliance with essential safety and performance requirements, but they generally undergo less stringent scrutiny compared to higher-risk classes. This classification allows for broader availability while maintaining regulatory oversight.