Akern Srl

Akern Srl specializes in bioimpedance analysis devices, which measure body composition and hydration status. Their portfolio includes hardware like the NUTRILAB PRO (nutritional assessment), BIVATRODES (electrode systems for bioimpedance), BODYGRAM HBO (body composition monitoring), EFG+ (advanced bioimpedance measurements), and BIA101 BIVA PRO (body water analysis). They also provide software solutions such as the Bodygram Dashboard and Telelab for remote data management and telemedicine, ensuring clinical and research applications are supported.

Akern Srl is based in Italy, which means its devices must comply with EU Medical Device Regulations (MDR) or EU In Vitro Diagnostic Regulation (IVDR), depending on classification. Since all its products are listed in EUDAMED, they are subject to EU-wide regulatory oversight, including conformity assessment procedures like Class I self-certification or Class IIa notified body involvement for higher-risk devices. Italy’s regulatory framework aligns with EU standards, ensuring devices meet safety, performance, and traceability requirements before market placement.

Akern Srl’s devices are listed in EUDAMED, the European Union’s medical device registry. This registry tracks device details, including manufacturer information, classification, and regulatory status, ensuring transparency for healthcare providers, regulators, and patients. Listing in EUDAMED confirms compliance with EU requirements and allows for easy verification of device authorisation status, which is critical for clinical use, procurement, and auditing under EU medical device laws.

Akern Srl’s devices fall into Class I (low-risk, e.g., some bioimpedance analyzers) and Class IIa (moderate-risk, e.g., devices requiring additional safety measures) under EU medical device regulations. Classification determines the regulatory pathway: Class I devices typically undergo self-certification by the manufacturer, while Class IIa devices require assessment by a Notified Body to confirm compliance with essential safety and performance requirements. This classification ensures devices meet appropriate risk-based standards before entering the market.