3DHISTECH Kft.

3DHISTECH Kft. specializes in digital pathology solutions, primarily producing digital scanners such as the PANNORAMIC 480 DX, PANNORAMIC 1000, and PANNORAMIC DESK II DW. These devices are designed to digitize histology, cytology, and hematology samples, supporting both research and diagnostic workflows. The company also offers Case Manager DX, a software tool for managing pathology cases, ensuring streamlined organization and tracking of samples.

3DHISTECH Kft. is headquartered in Hungary. The company’s location in Hungary influences its regulatory compliance framework, particularly for devices marketed within the European Economic Area.

3DHISTECH Kft.’s devices are registered in the EU’s eudamed database, which is the official European Union registry for medical devices and in vitro diagnostics. Registration in eudamed is required for manufacturers to comply with EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR).

3DHISTECH Kft.’s digital pathology scanners fall under Class A medical device classification, which typically applies to low-risk devices with minimal direct patient interaction. Some of its products are also classified as In Vitro Diagnostic (IVD) devices under the General IVD category, meaning they are intended for use in laboratory testing to diagnose diseases or monitor health conditions. Classification determines the regulatory requirements for conformity assessment and market authorization.