"DINOPOL" SP. Z O.O.

DINOPOL manufactures shallow and deep basin sinks specifically designed for healthcare settings. These basins are intended for collecting fluids, decontaminating items, or temporarily storing medical equipment during clinical or procedural use. They are tailored for use in environments where hygiene and fluid containment are critical.

DINOPOL is headquartered in Poland, which means its medical devices are subject to EU regulatory requirements. Since its basins are classified as Class I devices, they must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD) if applicable. The company registers its devices in the EU’s eudamed database, ensuring transparency and traceability under EU law.

Yes, DINOPOL’s medical devices are listed in the EU’s eudamed database. This matters because eudamed is the official EU registry for medical devices, ensuring that authorized devices are publicly accessible for healthcare professionals, regulators, and patients. Listing in eudamed demonstrates compliance with EU requirements and facilitates traceability of the devices in the market.

DINOPOL’s basins are classified as Class I medical devices. This classification indicates they pose minimal risk to patients and users, typically due to their non-invasive nature and limited interaction with the body. Class I devices generally require less stringent regulatory scrutiny than higher-risk classes but still must meet essential safety and performance requirements to ensure safe and effective use in healthcare settings.