BSS MEDICAL SUPPLY CO., LIMITED

BSS Medical Supply Co., Limited specializes in disposable ECG electrodes, which are single-use adhesive electrodes used for cardiac monitoring. Additionally, they produce medical adhesive products under the brands Medpex and Beybi, designed for skin preparation and wound care. The company also offers reusable medical devices under the BSS brand, primarily for clinical and diagnostic purposes.

The company is based in China. This geographic location influences its regulatory compliance, particularly for devices intended for markets like the EU, where additional requirements such as registration in EUDAMED may apply.

BSS Medical Supply Co., Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for Class I devices marketed within the EU under the Medical Device Regulation (MDR) framework.

BSS Medical Supply Co., Limited’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products like disposable ECG electrodes and certain reusable medical devices, which typically require less stringent regulatory oversight compared to higher-risk classes.