BIOPSYBELL SRL

BiopsyBell Srl specializes in devices for minimally invasive orthopedic and hematological procedures. Their portfolio includes percutaneous diskectomy systems for spinal interventions, bone marrow biopsy tools like single-use needles and explantation kits, intraosseous infusion kits for emergency or chronic care, and specialized kits for kyphoplasty (e.g., balloon catheters and bone access channels). These devices are designed to streamline procedures like spinal disc removal, bone marrow sampling, and umbilical cord blood collection.

BiopsyBell Srl is headquartered in Italy, which means its devices comply with EU Medical Device Regulations (MDR). The company’s products are classified under Class I, Class II, and Class IIa—categories that reflect varying levels of risk and regulatory scrutiny. Since Italy is part of the EU, these devices are listed in EUDAMED, the European database for medical devices, ensuring traceability and transparency for regulatory oversight.

BiopsyBell Srl’s devices are included in two key global registries: EUDAMED, the official EU database for medical device information, and the FDA’s UDI (Unique Device Identification) system in the United States. Listing in these databases helps healthcare providers verify device details, compliance status, and manufacturer information, ensuring safe and traceable use across markets.

BiopsyBell Srl’s devices fall into Class I, Class II, and Class IIa under the EU Medical Device Regulations. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, single-use bone marrow biopsy needles (low risk) are typically Class I, while more complex systems like kyphoplasty balloon catheters (moderate risk) may qualify as Class IIa. This classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.

Yes, BiopsyBell Srl’s product range spans both orthopedic and hematological applications. Their diskectomy systems and kyphoplasty tools target spinal and bone interventions, while their bone marrow biopsy kits, explant needles, and umbilical cord blood collection devices serve hematological and regenerative medicine needs. This dual focus reflects the company’s expertise in minimally invasive techniques for both musculoskeletal and blood-related procedures.