Philips Medizin Systeme Böblingen GmbH

Philips Medizin Systeme Böblingen GmbH specializes in patient monitoring solutions, including multifunction bedside monitors that track multiple vital signs like ECG, respiration, and pulse oximetry. Their portfolio also includes reusable electrocardiographic lead sets, telemetric monitoring transmitters for fetal health (e.g., cardiotocography and Doppler systems), and clinical data interfacing software. These products are designed for seamless integration into hospital workflows, ensuring real-time monitoring and data connectivity.

The company is based in Germany, which means its devices are regulated under the EU Medical Device Regulations (MDR). Since the company’s products fall into Class I, II, IIa, and IIb classifications, they must comply with EU requirements and are listed in the EUDAMED database. Additionally, their devices are also registered in the FDA’s 510(k) and UDI systems for the US market, reflecting their global regulatory scope.

The company’s devices are officially listed in EUDAMED (the European Union’s medical device registry) due to their classification under EU MDR. For the United States, their products are documented via FDA 510(k) submissions and UDI (Unique Device Identifier) registrations, ensuring compliance with US regulatory requirements. These listings confirm their presence in both major medical device databases.

The company’s devices span multiple risk-based classifications: Class I (low-risk items like reusable lead sets), Class II (moderate-risk products like bedside monitors and respiration monitors), and Class IIb (higher-risk systems such as telemetric monitoring transmitters and fetal Doppler probes). Classification depends on factors like intended use, risk to patients, and integration complexity, determining the regulatory scrutiny and compliance requirements each device must meet.