Contec Medical Systems (Qinhuangdao) Co., Ltd. has recently obtained a medical device registration certificate from the Hebei Medical Products Administration for its bi-level positive airway pressure therapy device, model R100BP. The certificate number is 冀械注准20262080182, valid until July 1, 2031. The device is used to alleviate snoring, hypopnea, and sleep apnea during sleep in patients weighing over 30 kilograms, and is suitable for use in homes, clinics, and hospitals. Meanwhile, the company completed registration certificate changes for three products: the medical infrared thermometer reduced model TP550 and changed its structure, composition, and technical requirements; the infusion pump added model SP770 and changed technical requirements and scope of application, explicitly stating it is not for infusion of blood products, analgesic drugs, chemotherapy drugs, or insulin; and the blood oxygen and ECG device data management software changed its structure, composition, and technical requirements. The company stated that the new registration certificate will enrich its product line and the changes will optimize product performance, but the specific impact on sales cannot yet be predicted.
Contec Medical Systems Co LtdReceived medical device registration certificate for bi-level positive airway pressure therapy device, enabling market access.