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FDA 510(k)-cleared device manufacturing under ISO 13485:2016

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1 fda 510(k)-cleared device manufacturing under iso 13485:2016 supplier across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

AIDAR HEALTH, INC.

PIKESVILLE, MD

AIDAR Health is a Columbia, Maryland-based medical technology company that developed MouthLab, an FDA 510(k)-cleared multi-parameter physiologic monitor that captures 10+ clinical-grade vital measurements from one breath in 60 seconds. Its cloud-based analytics engine, AIDI, scores the whole body from 0 to 100 and tracks trends to enable early warning. MouthLab was born at Johns Hopkins Medicine, and the company was founded in 2018 as Multisensor Diagnostics.

breath-based vital sign measurementcloud-based analyticsremote patient monitoring

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