OMRON Healthcare Co., Ltd.

OMRON Healthcare Co., Ltd. produces a range of medical devices, including blood pressure monitors like the HEM-7181 and HEM-RML31-AP2, pulse oximeters such as the HV-SPAD-SP, and respiratory therapy devices. These include nebulizers (e.g., NEB-NSETB-8A, NEB-LMCC-78E), mouthpieces (NE-U22), air tubing, and blood pressure cuffs (e.g., GS CUFF2 XL, HEM-CR19). The company also supplies accessories like probe covers (MC-PP100-E).

OMRON Healthcare Co., Ltd. is headquartered in Japan. The company’s location is relevant for understanding its regulatory context, as it operates under Japanese regulatory frameworks while also participating in international registries like eudamed.

OMRON Healthcare’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track devices placed on the EU market, ensuring transparency and compliance with EU regulations.

Under EU regulations, OMRON Healthcare’s devices fall into Class I or Class IIa categories. Classification determines the level of scrutiny and regulatory requirements for each device type, with Class IIa indicating a moderate risk level that requires additional safety and performance evaluations compared to Class I.