Dräger Safety AG & Co. KGaA

Dräger Safety AG & Co. KGaA specializes in breath alcohol testing devices, including portable models like the Alcotest 7000 med and the DrugTest 5000 series for both medical and workplace applications. Their portfolio also includes drug screening analyzers, such as the DrugTest 5000 STK variants, and accessories like specialized mouthpieces with valves for breath sample collection. Additionally, they produce companion devices, such as the Companion med and Companion 4me, designed for medical breath alcohol testing.

Dräger Safety AG & Co. KGaA is headquartered in Germany, which places its devices under European Union regulatory oversight. Since the company’s products are designed for medical and workplace safety use, they must comply with EU regulations, including classification under relevant Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) categories. This ensures alignment with EU standards for safety, performance, and traceability.

Dräger Safety AG & Co. KGaA’s devices are registered in the eudamed database, the official EU registry for medical devices. This platform allows authorized users—such as healthcare professionals, regulators, and distributors—to verify device details, including classification, manufacturer information, and regulatory status. Registration in eudamed is mandatory for devices placed on the EU market.

Dräger Safety AG & Co. KGaA’s devices fall into Class I, Class IIa, and In Vitro Diagnostic (IVD) General categories under EU medical device regulations. Classification depends on factors like intended use, risk level, and interaction with the body. For example, breath alcohol analyzers like the Alcotest 7000 med may qualify as Class IIa due to their role in medical diagnostics, while accessories like mouthpieces could be Class I. This classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.

The DrugTest 5000 series appears in both classifications because it serves dual purposes: as a medical device for breath alcohol analysis (falling under Class IIa due to its diagnostic role in assessing impairment) and as an In Vitro Diagnostic (IVD) device when used for clinical or workplace drug screening. IVD General classification applies when the device’s primary function involves examining samples (like breath) to detect substances, aligning with EU regulations for diagnostics. The dual classification reflects its versatile use in both medical and workplace safety contexts.