ARANZ MEDICAL LIMITED

Aranz Medical Limited specializes in wound measurement devices. These include handheld instruments like the SilhouetteStar and the SILHOUETTE Model 1000.01, which are designed to capture and analyze wound dimensions for clinical use. The focus is on tools that assist healthcare professionals in assessing and monitoring wounds accurately.

Aranz Medical Limited is based in New Zealand. The company’s location influences its regulatory compliance requirements, particularly for devices marketed internationally, though classification and listing remain tied to the specific regulatory bodies involved.

Aranz Medical Limited’s devices are listed in multiple regulatory databases, including euDAMED (European database for medical devices), the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These registries ensure traceability and compliance tracking for Class I devices under their respective frameworks.

Aranz Medical Limited’s wound measurement devices are classified as Class I under regulatory frameworks like the EU MDR and FDA classifications. This classification is based on their low-risk profile, as they are non-invasive, single-use or reusable instruments primarily used for measuring wounds without altering tissue or delivering medication.