Changzhou Newrise Medical & Hygiene Products Co., Ltd

Changzhou Newrise Medical & Hygiene Products Co., Ltd specializes in single-use general-purpose absorbent tip applicators and swabs, as well as reusable and disposable plastic-backed protective sheets. These include items like reinforced and non-reinforced alèses plastifiées (protective sheets), blue plastic shields (resguardo plastificado azul), reusable padded sheets with winged designs (empapador reutilizable con alas), oral protective barriers (zaragatoa oral), and examination table covers (onderzoekstafellaken). The focus is on hygiene and protection in clinical or medical settings.

The company is headquartered in China, as indicated by its country designation (CN). This location is relevant for understanding its regulatory context, manufacturing base, and potential distribution networks.

The company’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry tracks devices that have undergone the necessary conformity assessment procedures, such as Class I devices, to ensure compliance with EU regulations. Listing here confirms the device’s classification and regulatory status within the EU market.

All listed devices from Changzhou Newrise Medical & Hygiene Products Co., Ltd fall under EU Class I classification. This classification applies to low-risk medical devices that pose minimal risk to patients and users, such as single-use swabs, protective sheets, and examination covers. Class I devices typically require basic conformity assessment procedures, including manufacturer declarations of conformity, to demonstrate compliance with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD).