Dan Medica South Ltd

Dan Medica South Ltd manufactures the TREAT-EEZI, a Class I medical device. Based on the description, this device appears to be intended for wound care or minor skin treatments, likely suitable for either at-home or clinical use. Class I devices are generally considered low-risk and often include items like bandages, wound dressings, or simple skin treatment tools.

Dan Medica South Ltd is based in the United Kingdom (GB). This location is relevant for regulatory compliance, as it influences which regulatory bodies and databases the company interacts with, such as the EU’s eudamed registry.

Dan Medica South Ltd’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices within the European Economic Area. Listing in eudamed is required for compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring transparency and traceability of Class I devices.

Dan Medica South Ltd’s devices, such as the TREAT-EEZI, are classified as Class I under medical device regulations. This classification is determined by factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class I devices are typically the lowest risk and often require minimal regulatory oversight, though compliance with general safety and performance requirements still applies.