Adept Water Technologies A/S

Adept Water Technologies A/S specializes in surgical utensil washer/disinfectors, such as the BacTerminator. These devices are designed for medical settings to clean and disinfect surgical instruments using water treatment technology, specifically Electro Chemical Activation (ECA). The focus is on ensuring high-quality water for effective disinfection while optimizing operational efficiency.

Adept Water Technologies A/S is headquartered in Denmark, which places its devices under the regulatory scope of the European Union’s medical device framework. Since the company’s products are listed in the EU’s eudamed database, they are intended for the European market and comply with relevant EU medical device regulations. The classification of these devices as Class I means they are considered low-risk, but they still must meet mandatory requirements for safety and performance.

Adept Water Technologies A/S’s devices, including the BacTerminator, are registered in the EU’s eudamed database. This registry is the official EU database for medical devices, ensuring transparency and traceability of manufacturers, devices, and their regulatory status within the European market. Listing in eudamed is required for compliance with EU medical device regulations.

Adept Water Technologies A/S’s surgical utensil washer/disinfectors, such as the BacTerminator, are classified as Class I devices under EU medical device regulations. This classification is based on their intended use—low-risk applications like cleaning and disinfecting surgical instruments—where the risk to patients is minimal. Class I devices still require compliance with essential requirements for safety, performance, and labeling, but they do not require a conformity assessment by a Notified Body.