AVA Sciences-FMTC GmbH

AVA Sciences-FMTC GmbH specializes in reusable wearable devices that continuously monitor multiple physiological parameters. These devices are designed for non-invasive, long-term health tracking in consumer settings, such as fertility monitoring. The primary category is a wearable multiple physiological parameter recorder, which captures data like heart rate variability, body temperature, and movement patterns to support applications like fertility awareness.

The company operates from the United States. While the exact location isn’t specified, its regulatory filings and device listings are associated with the U.S. jurisdiction, indicating its primary operational base.

AVA Sciences-FMTC GmbH’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the U.S., allowing healthcare providers, regulators, and consumers to verify device details like manufacturer information, model identification, and classification.

The company’s devices fall under FDA Class II (categorized as ‘U’ for *Unclassified* under the FDA’s classification system). This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as reusable wearables for physiological monitoring. The classification is determined based on factors like intended use, duration of use, and potential health impact.