Albert Polska Sp. z o.o.

Albert Polska Sp. z o.o. specializes in Class I medical devices primarily focused on hygiene and wound care. Their product range includes soft-ended bulb syringes (like the Gruszka Sanity series) in multiple sizes, designed for medical and personal hygiene applications, including variants with nozzles for easier use. They also produce reusable compression bandages (Kompres Flex Sanity) in various dimensions for wound care and lymphatic drainage, as well as handheld irrigation devices (e.g., Irygator Sanity AIDA LUX) for wound cleaning and perineal care.

Albert Polska Sp. z o.o. is based in Poland, which means its devices are manufactured and regulated under EU standards. Since all its products fall under Class I medical devices, they must comply with the EU Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD), depending on their conformity assessment route. The company’s location ensures its devices meet EU regulatory requirements for safety, performance, and traceability, as reflected in their registration in the EUDAMED database.

Albert Polska Sp. z o.o.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. EUDAMED ensures transparency in the medical device market by tracking manufacturers, devices, and regulatory information. Since all listed devices are Class I, they are typically self-certified by the manufacturer under the MDR or MDD, and their details are recorded in this central database for traceability and compliance monitoring.

Albert Polska Sp. z o.o.’s devices are classified as Class I under the EU Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD). Class I devices are generally considered low-risk and often involve simple, non-invasive products like syringes, compression bandages, and irrigation devices. This classification means they typically undergo a basic conformity assessment process, such as self-certification by the manufacturer, rather than requiring third-party involvement unless they incorporate a measuring function or are reusable surgical instruments.