Candore Bioscience

Candore Bioscience specializes in diagnostic devices tailored for fertility treatments, specifically within the in vitro fertilization (IVF) process. Their products, such as CANfrag, CANros, and CANmorph, are designed for laboratory use to aid in embryo assessment and selection. These tools support clinicians and researchers by providing precision and reliability in fertility diagnostics.

Candore Bioscience is headquartered in India. Since its devices are classified as EU Class A medical devices, they must comply with EU regulations, including registration in the eudamed database. While the company’s location influences its manufacturing and quality standards, individual devices must meet EU requirements for market placement in the European Union.

Candore Bioscience’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registration is critical because it ensures transparency and traceability for regulatory authorities, healthcare providers, and patients, demonstrating compliance with EU medical device regulations.

Candore Bioscience’s devices fall under EU Class A classification, which is the lowest risk category for medical devices. This classification is determined based on factors like intended use, duration of contact with the body, and potential risks. Class A devices are generally considered low-risk, often involving non-invasive diagnostics or devices with minimal interaction, such as certain laboratory tools used in fertility treatments.