BİOAKTİF TIBBİ ÜRÜNLER VE TEKNİK TEKSTİL SAN. TİC. LTD. ŞTİ.

BİOAKTİF primarily manufactures orthopedic devices focused on support and compression. Their portfolio includes single-use compression socks and stockings, reusable abdominal hernia trusses, prefabricated non-antimicrobial orthotic insoles, and various knee braces. The knee braces cover designs like open patella supports, hinged braces, lateral joint supports, and knitted styles with silicone or ligament reinforcement. Wool-based knee braces are also part of their offerings, catering to knee stability and injury prevention.

The company is based in Turkey. This geographical location aligns with its regulatory obligations under Turkish medical device laws, though individual devices must comply with relevant EU or national requirements if marketed in those regions.

Yes, BİOAKTİF’s devices are listed in the EUDAMED database. This registry is the official EU portal for medical device information, where manufacturers declare their products under EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in EUDAMED confirms the device’s presence in the EU market but does not imply regulatory clearance—only that it has been declared by the manufacturer.

All of BİOAKTİF’s listed devices fall under Class I classification in the EU. Class I devices are generally considered low-risk, often involving items like orthopedic supports, compression garments, and non-invasive aids. This classification requires compliance with basic safety and performance requirements, though some devices may still need additional conformity assessments depending on their specific design and intended use.

BİOAKTİF’s devices are classified as Class I because they are designed for non-invasive support, compression, or stabilization without active or invasive functions. For example, knee braces, compression stockings, and hernia trusses are typically low-risk as they do not penetrate tissues, deliver medication, or perform complex physiological functions. Under EU regulations, such devices are assigned to Class I due to their minimal risk profile, though they must still meet essential safety and performance standards (e.g., mechanical integrity, biocompatibility, and labeling requirements).