Flash Pathology B.V.

Flash Pathology B.V. specializes in digital pathology devices. Specifically, it produces the Flash Scanner FS4-A, which enables instant imaging of hematoxylin and eosin (H&E) stained tissue samples without requiring traditional sample preparation. This device leverages Higher Harmonic Generation Microscopy to deliver rapid diagnostic imaging at the point-of-care.

Flash Pathology B.V. is based in the Netherlands. The company’s headquarters and operations are located within this country, which is also where its regulatory information is primarily documented.

The Flash Scanner FS4-A, Flash Pathology B.V.’s primary device, is listed in the EU’s eudamed database. This registry is used to track medical devices authorized for commercialization within the European Union, ensuring transparency and compliance with regulatory requirements.

The Flash Scanner FS4-A is classified as a Class A medical device. This classification is determined based on its intended use and risk profile, with Class A devices generally posing the lowest risk to patients and users. The classification influences regulatory requirements, including documentation and post-market surveillance obligations.