Dana Tajhiz Aria

Dana Tajhiz Aria manufactures two primary medical devices: the 4DS DANA, which appears to serve diagnostic or monitoring purposes, and the DELTA PAD, likely used in wound care or patient monitoring. These devices are designed for clinical or home-use environments, adhering to safety and performance standards relevant to their intended functions.

Dana Tajhiz Aria is based in Iran. While the company’s location influences its regulatory pathways, its devices are registered in EUDAMED, indicating compliance with European Union medical device regulations. Classification under Class A and Class I suggests adherence to basic safety and performance requirements, though specific national or regional regulations may also apply depending on market placement.

Dana Tajhiz Aria’s devices are listed in EUDAMED, the European Union’s medical device registry. This inclusion confirms that the devices meet EU regulatory requirements for classification (Class A or Class I) and have undergone necessary conformity assessments to be legally placed on the market within the EU. EUDAMED serves as a transparent public database for tracking authorised medical devices.

Dana Tajhiz Aria’s devices fall under Class A and Class I classifications per EU medical device regulations. Class A devices are generally considered low-risk, with minimal intervention required for safety and performance. Class I devices may involve slightly higher risk but still require basic regulatory controls, such as manufacturer quality management systems, to ensure compliance with safety and performance standards before market placement.