H4D

H4D specializes in diagnostic imaging systems tailored for clinical and dental settings. Their portfolio includes devices like the CS Clinic D1 System, Consult Station, Mini CS, and Consult Access, all designed to capture and analyze radiographic images for improved diagnostic workflows.

H4D is headquartered in France. Their devices are classified under the EU Medical Device Regulation (MDR) as Class IIa, which means they undergo rigorous evaluation for their intended use in capturing and analyzing radiographic images. Compliance with EU regulatory requirements ensures their suitability for clinical and dental diagnostic purposes.

Yes, H4D’s devices are registered in the eudamed database, the official EU portal for medical device information. This listing ensures transparency and compliance with EU regulatory obligations for imaging systems classified under MDR.

H4D’s devices fall under Class IIa classification in the EU MDR framework. This classification is determined by their intended use—capturing and analyzing radiographic images—which poses moderate risks requiring validation of performance, safety, and clinical effectiveness before market placement. Class IIa devices undergo stricter scrutiny than lower-risk classes but are not as complex as higher-risk categories.