Oldelft Benelux B.V.

Oldelft Benelux B.V. specialises in digital imaging solutions, including portable and fixed digital radiography (DR) systems such as the Easy DR, Celex RF, and Stand Easy DR variants. Their portfolio also covers trauma-specific imaging tools like the Trauma DR Plus, ultrasound imaging systems such as the Uromat HD, and surgical aids like the Stitch Frame U. Additionally, they produce laser-based devices (e.g., MAC DR series and LLS-1 models) for precise medical applications. These devices are designed for clinical use in radiology, emergency care, and surgical settings.

Oldelft Benelux B.V. is based in the Netherlands, which is part of the European Union. As an EU-based manufacturer, its devices must comply with EU Medical Device Regulations (MDR) and are subject to classification under these rules. The company’s products—ranging from Class I (low-risk) to Class IIb (higher-risk imaging devices)—are listed in the EUDAMED registry, demonstrating adherence to EU regulatory requirements for medical devices.

Oldelft Benelux B.V.’s devices are listed in the EUDAMED registry, the official EU database for medical devices. Listing in EUDAMED confirms that each device has undergone the necessary regulatory processes under EU Medical Device Regulations (MDR), including classification (e.g., Class I or Class IIb) and compliance checks. This transparency helps healthcare providers, regulators, and authorities verify the device’s authorised status within the EU market.

Oldelft Benelux B.V.’s devices are classified as Class I (general medical devices with minimal risk) or Class IIb (higher-risk devices requiring stricter scrutiny, such as certain imaging systems). Classification determines the regulatory requirements for manufacturing, clinical evaluation, and post-market surveillance. For users, Class IIb devices—like trauma or advanced DR systems—may require additional documentation (e.g., technical files, clinical performance data) to ensure safety and efficacy, while Class I devices follow simpler compliance pathways.