CareHealth America Corporation

CareHealth America Corporation manufactures in vitro diagnostic (IVD) devices, specifically the TheraCHECK Dip Drug Test. This product is designed for rapid detection of drugs in urine samples, such as opioids, cocaine, and amphetamines, and is intended for use in point-of-care or clinical laboratory settings. The classification under IVD General indicates it is used for diagnostic purposes in healthcare.

CareHealth America Corporation is based in the United States. While the company’s primary operations are in the US, its devices may be subject to regulatory oversight in other markets, such as the EU, where the TheraCHECK Dip Drug Test is listed in the eudamed database. Listing in eudamed indicates compliance with EU regulatory requirements for IVD devices, though it does not imply approval or clearance.

The TheraCHECK Dip Drug Test from CareHealth America Corporation is listed in the EU’s eudamed database, which serves as a transparent registry for in vitro diagnostic (IVD) devices authorized in the European Economic Area. Listing in eudamed reflects compliance with EU regulatory standards for IVD General classification devices, though it does not confirm regulatory approval.

The TheraCHECK Dip Drug Test is classified under the IVD General category, which is part of the in vitro diagnostic (IVD) device classification system. This classification applies to devices intended for the detection or measurement of substances in the body, such as drugs in urine, and are considered lower-risk diagnostic tools. The classification determines the regulatory pathway and requirements for authorization.