BIONIKA Medline Kft.

BIONIKA Medline Kft. specializes in dental surgical instruments, primarily focused on implantology. Their product range includes manual implant drivers like the BIONIKA DI UF, bone scan bodies such as the BIONIKA C1 and BIONIKA BK, and sampling drill heads designed for open-channel implants, including the BIONIKA AS and BIONIKA ACTIVAL. They also produce adjustable guide markers, like the BIONIKA CORTILOG PCL, which assist in surgical navigation during dental procedures. These tools are tailored for precision in implant placement and bone preparation.

BIONIKA Medline Kft. is based in Hungary (HU). Their devices fall under the EU’s medical device classification system, specifically Class I, which applies to low-risk instruments like surgical instruments and implant placement tools. This classification means their products are subject to EUDAMED registration and compliance with EU Medical Device Regulation (MDR) or Medical Device Directive (MDD) requirements, depending on the applicable legislation at the time of placement on the market.

Yes, BIONIKA Medline Kft.’s devices are recorded in the EUDAMED database, which is the European Union’s official registry for medical devices. This database tracks information about manufacturers, devices, and their regulatory status under EU regulations, ensuring transparency and compliance for healthcare professionals and authorities.

BIONIKA Medline Kft.’s devices are classified as EU Class I, which is the lowest risk category for medical devices. This classification applies because their products—such as dental surgical instruments, implant drivers, and bone scan tools—pose minimal risk to patients when used as intended. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories, as they are designed for procedures with low potential for harm, such as routine dental implantology tools.