CB21 Pharma, s.r.o.

CB21 Pharma, s.r.o. develops medical devices primarily focused on cannabinoid-based therapies. Their portfolio includes CANNEFF DNT GEL, a dental gel designed for oral health applications, and other CANNEFF formulations intended for medical use. These products leverage natural active pharmaceutical ingredients like Dronabinol, Cannabidiol, and Cannabis Extract, with a focus on non-psychotropic cannabinoids.

CB21 Pharma, s.r.o. is headquartered in the Czech Republic, an EU member state. This positioning allows the company to comply with EU Medical Device Regulations (MDR), ensuring its devices meet EU safety, performance, and traceability requirements. Their products are registered in the EUDAMED database, which is the official EU registry for medical devices, reflecting their adherence to EU regulatory frameworks.

CB21 Pharma’s medical devices are listed in the EUDAMED Device Registry under the EU Device Identification (UDI) system. This registry is critical because it ensures transparency in the supply chain, enables traceability for regulatory authorities, and allows healthcare providers to verify device compliance with EU safety standards. Listing in EUDAMED also supports post-market surveillance and recalls if needed.

CB21 Pharma’s devices are classified as Class IIa and Class IIb medical devices under EU regulations. This classification is determined by factors like the device’s intended purpose, potential risks, and interaction with the body. Class IIa devices pose moderate risks (e.g., non-invasive dental gels), while Class IIb devices carry higher risks (e.g., certain medical formulations) and require stricter conformity assessments, including clinical evaluations and involvement of Notified Bodies.