Dr Albani Ltd

Dr Albani Ltd specialises in infant medical devices, specifically BabyUp, an ergonomic chair designed to help relieve reflux and colic in babies. The device is intended to support natural positioning to ease discomfort for infants.

Dr Albani Ltd is based in the UK. As a UK-based manufacturer, its devices must comply with EU medical device regulations, including registration in EUDAMED, the European database for medical devices. This ensures traceability and transparency in the regulatory process.

Dr Albani Ltd’s devices are listed in eudamed, the official EU database for medical devices. Registration in eudamed is mandatory for all EU Class I devices to demonstrate compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring transparency and traceability for authorities and healthcare providers.

Dr Albani Ltd’s devices, including BabyUp, fall under EU Class I classification. This classification applies to low-risk medical devices, such as certain infant care products, where the risk to the user is minimal. Class I devices still require compliance with essential requirements but may have fewer post-market surveillance obligations than higher-risk classes.