Neatech.it

Neatech.it specializes in mobility aids designed to support individuals with limited mobility. Their product range includes standing frames like the PEEZY and BEK SHIFT, powered and manual standing/walking devices such as the TALLY POWERED and TALLY MANUAL, as well as transfer aids like the jobbette and STEADY. They also produce adjustable height supports (e.g., EVO3 FWD WITHOUT LIFT) and round-based standing devices (e.g., BEK ROUND). The portfolio covers both lightweight models (e.g., PEEZY LIGHT) and high-capacity solutions (e.g., XTREME) for use in clinical and home environments.

Neatech.it is based in Italy, which places their devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since all their products fall under Class I—defined as low-risk devices—they must comply with EU safety and performance standards. This includes registration in the EUDAMED database, ensuring transparency and traceability for authorized devices within the EU market.

Neatech.it’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry is critical because it provides authorized devices’ identification, classification, and regulatory status to healthcare professionals, regulators, and patients. For Class I devices, EUDAMED ensures compliance with MDR requirements, including traceability and market surveillance.

Neatech.it’s devices are classified as Class I under the EU Medical Device Regulation (MDR), which categorizes them as low-risk products. This classification means they undergo minimal regulatory scrutiny compared to higher-risk devices but still must meet essential safety and performance requirements. For users, this classification implies a lower risk profile, though compliance with MDR ensures they remain safe and functional for their intended purpose.

Neatech.it’s devices are registered in EUDAMED because it is the mandatory EU database for medical devices, ensuring transparency and traceability. For Class I devices like those produced by Neatech.it, EUDAMED records details such as the device’s name, classification, manufacturer information, and regulatory status. This helps healthcare providers verify the device’s authorized status and compliance with EU safety standards before use.