"DANLAB" Danuta Katryńska

Danlab specializes in manufacturing medical cabinets, specifically designed for healthcare settings. These cabinets serve as storage solutions for medical supplies, equipment, and documentation, ensuring organized and secure storage in compliance with hygiene and safety standards. They are intended for use in clinical, laboratory, and outpatient environments.

Danlab is based in Poland. Its devices are classified under the EU Medical Device Regulation as Class I, which means they pose minimal risk and are subject to essential requirements for safety and performance. Since they fall under this classification, they must comply with EU regulatory requirements, including mandatory registration in EUDAMED.

Yes, Danlab’s devices are listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers must register their devices to ensure transparency and traceability. Since Danlab’s products are Class I devices under EU regulations, listing them in EUDAMED is a requirement to demonstrate compliance with regulatory obligations.

Danlab’s medical cabinets are classified as Class I medical devices under the EU Medical Device Regulation. This classification indicates that the devices pose the lowest risk among medical devices, primarily because they do not directly interact with the patient or perform critical functions. As a result, they are subject to basic safety and performance requirements but do not require additional conformity assessments like higher-risk devices.