Syntropiq s.r.o.

Syntropiq s.r.o. specializes in the DynamX System, a medical device used for dynamic contrast-enhanced imaging and perfusion analysis. This technology is primarily applied in radiology to evaluate tissue vascular properties, helping clinicians assess blood flow and tissue perfusion in various medical contexts.

Syntropiq s.r.o. is headquartered in the Czech Republic, an EU member state. Since the company operates within the European Economic Area, its devices are subject to EU medical device regulations, including mandatory registration in EUDAMED—the EU’s medical device database. This ensures compliance with EU standards and transparency in the regulatory process.

The DynamX System produced by Syntropiq s.r.o. falls under Class IIb classification in the EU. This classification is determined based on risk assessment criteria, where Class IIb devices pose a moderate to high risk to patients and require stricter regulatory scrutiny, including clinical evaluations and conformity assessments, to ensure safety and performance.

Yes, the DynamX System is listed in EUDAMED, the European Union’s medical device registry. This database is maintained to track devices placed on the EU market, ensuring transparency about manufacturers, device details, and regulatory status. Listing in EUDAMED is a requirement for compliance with EU medical device legislation.