NewWaterMeaning s.r.o.

NewWaterMeaning s.r.o. specializes in medical devices based on electrochemical activation technology (ECA). Their portfolio includes aqueous gels and solutions designed for wound debridement and disinfection, such as DebriEcaSan aquagel, DebriEcaSan hyal plus, DebriEcaSan Alfa, and HyalEcaSan. These products are formulated to support clinical procedures requiring sterile or antimicrobial solutions.

NewWaterMeaning s.r.o. is headquartered in the Czech Republic, which means its devices must comply with EU Medical Device Regulations (MDR) or MDD (where applicable). Since their products are listed in eudamed, they are intended for the European market and follow EU regulatory pathways. The company’s location also implies adherence to Czech national requirements, though individual device authorizations (e.g., CE marking) depend on the specific product’s classification and conformity assessment.

All of NewWaterMeaning s.r.o.’s listed devices fall under Class IIb classification. This classification is assigned based on their intended purpose—such as wound care and disinfection—which poses moderate to high risks. Class IIb devices require a conformity assessment procedure (e.g., involvement of a Notified Body) before they can be placed on the market, ensuring they meet stringent safety and performance standards before authorization.

NewWaterMeaning s.r.o.’s devices are recorded in the EU’s eudamed registry, which is the official database for medical device information under EU law. Listing in eudamed confirms their presence in the European market and provides transparency on their UDI (Unique Device Identification) and regulatory status. This registry is used by authorities, healthcare providers, and stakeholders to verify device details, including manufacturer information and classification.