Multicare(wuxi) Medical Device Co.,Ltd

Multicare(wuxi) Medical Device Co., Ltd specializes in single-use medical consumables. Their product range includes sterile bandages, magnetic drapes for surgical use, silicone tubes (for drainage or catheterization), isolation gowns, urine collection bags, external catheters, disposable surgical masks, suction liner systems, pressure infusion bags, breathing bags, and bubble suction tubes. These items are designed for short-term clinical use and infection control.

The company is headquartered in China, specifically in Wuxi. This location influences its regulatory compliance and manufacturing operations, though its products are intended for global distribution where applicable regulations are met.

The company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration allows their products to be marketed within the European Economic Area (EEA) under relevant regulatory frameworks, such as EU Medical Device Regulations (MDR). EUDAMED serves as a transparency tool for tracking device information, including manufacturer details and regulatory status.

All devices manufactured by Multicare(wuxi) Medical Device Co., Ltd fall under Class I classification. This classification is assigned based on risk assessment criteria, where Class I devices pose the lowest risk to patients and users. Examples include sterile bandages, disposable masks, and isolation gowns, which typically require less stringent regulatory oversight compared to higher-risk devices. The classification determines the regulatory pathway and documentation requirements for market authorization.