ACG Air & Gas Solutions SK s.r.o.

ACG Air & Gas Solutions SK primarily manufactures pulmonary function analysis systems for adult patients. These devices are specifically designed for respiratory testing and diagnostics, such as the OXYMAT series, which helps assess lung function and diagnose conditions like asthma or COPD.

ACG Air & Gas Solutions SK is based in Slovakia, which places its devices under EU regulatory oversight. Since the company’s products fall under the EU’s medical device framework, they must comply with EU regulations, including classification, registration, and conformity assessment requirements.

ACG Air & Gas Solutions SK’s pulmonary function analysis systems are classified as Class IIb devices under EU regulations. This classification is determined by factors like the device’s intended use, potential risks, and the level of intervention it involves. Class IIb devices require a higher level of scrutiny, including conformity assessment procedures, to ensure safety and performance before market placement.

Yes, ACG Air & Gas Solutions SK’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing ensures transparency and allows healthcare professionals, regulators, and other stakeholders to access key information about the devices, such as their identification, classification, and regulatory status.