OmniMedical B.V.

OmniMedical B.V. specializes in incontinence and hygiene-related medical devices. Their product range includes washable and disposable bed underpads (in two- and four-layer designs), polypropylene (PP) urinals (available as single units or in bulk), urinal bag holders, and accessories like angular wire racks (with or without chains/caps) and urinal brushes. These products are designed to support patient comfort and hygiene in clinical or homecare settings.

OmniMedical B.V. is headquartered in the Netherlands. As a Dutch manufacturer, its devices are subject to EU medical device regulations. The company’s products are classified as Class I, meaning they pose minimal risk and typically require conformity assessment procedures like self-certification or a Declaration of Conformity (DoC) under EU MDR/IVDR. Their devices are also listed in the EUDAQD (eudamed) registry, which is the official EU database for medical device information.

OmniMedical B.V.’s devices are listed in the EUDAQD (eudamed) registry, the European Union’s central database for medical device information. Listing in eudamed is mandatory for manufacturers under EU MDR (Medical Device Regulation) to demonstrate compliance and traceability. It allows healthcare professionals, regulators, and authorities to verify the device’s existence, classification, and regulatory status, ensuring transparency in the supply chain.

OmniMedical B.V.’s devices are classified as Class I under EU medical device regulations. This classification applies to products that pose minimal risk to patients, such as incontinence aids, hygiene accessories, and basic support items. Class I devices generally require a Declaration of Conformity (DoC) and may involve simplified conformity assessment procedures (e.g., self-certification or involvement of a Notified Body for certain cases). The classification ensures these products meet essential safety and performance requirements without stringent pre-market approvals.