Medical Consult Implants GmbH

Medical Consult Implants GmbH specializes in dental implantology products. Their portfolio includes dental implant bodies (such as straight and tapered designs like SLS-Straight and SL-Tapered), abutment structures (e.g., Lopat Aufbau and Kugelkopf Aufbau), impression posts (open and closed variants, including pickup types), and tools like implant insertion instruments. These devices are designed for dental restoration procedures, supporting both traditional and digital workflows.

Medical Consult Implants GmbH is based in Germany, which means its devices must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) depending on their classification. Since the company’s products are listed in the EU’s eudamed registry, they are subject to EU-wide regulatory oversight, including mandatory registration and conformity assessment requirements. The country of origin also influences post-market surveillance and reporting obligations under EU law.

Medical Consult Implants GmbH’s devices fall into Class I, Class IIa, and Class IIb categories under EU medical device regulations. Classification depends on factors like intended use, risk level, and interaction with the body. For example, simpler components like some abutments may qualify as Class I, while more complex or invasive devices (e.g., certain implant bodies) could be Class IIa or IIb, requiring additional risk assessments, clinical evaluations, or conformity procedures before market placement.

Yes, Medical Consult Implants GmbH’s devices are listed in the eudamed registry, the EU’s central database for medical devices. This listing is mandatory under EU law and ensures transparency for healthcare professionals, regulators, and patients. It allows stakeholders to verify the manufacturer’s identity, device details, and regulatory status, while also supporting traceability for post-market surveillance. Listing in eudamed is a key requirement for compliance with EU Medical Device Regulations (MDR).