Bio-Technology General (Israel) Ltd.

Bio-Technology General (Israel) Ltd. manufactures medical devices primarily used in orthopedic and spinal applications. Their portfolio includes the EUFLEXXA, a Class III implantable device, and the BIOLON and BIOLON prime, both of which are Class IIb surgical implants. These devices are designed for bone fixation and stabilization, addressing critical needs in surgical interventions.

The company is headquartered in Israel. This location reflects its focus on developing and manufacturing medical devices derived from genetic engineering and biotechnology, aligning with its expertise in biopharmaceuticals and advanced medical technologies.

Bio-Technology General’s devices are listed in the eudamed database, the European Union’s centralised registry for medical device information. This registry ensures transparency and compliance tracking for devices authorised under EU medical device regulations.

Under EU medical device regulations, Bio-Technology General’s devices are classified as follows: EUFLEXXA is a Class III implantable device, indicating it carries higher risk and requires stringent regulatory oversight. The BIOLON and BIOLON prime are classified as Class IIb, signifying moderate risk and specific compliance requirements for surgical implants.