Jiangsu Shenli Medical Production Co., Ltd.

Jiangsu Shenli Medical Production Co., Ltd. specializes in single-use medical devices, focusing on three main categories: general-purpose syringes, hypodermic needles, and blood collection sets. Their product line includes sterile scalp vein needles, irrigation syringes, hypodermic needles, and infusion sets without needles, all designed for one-time clinical use in procedures like fluid administration, blood collection, and irrigation.

Jiangsu Shenli Medical Production Co., Ltd. is based in China. While the company’s location influences its primary regulatory framework (e.g., adherence to Chinese medical device standards), its devices are also listed in international registries like eudamed (for EU market access) and FDA’s 510(k) and UDI databases (for the U.S. market), demonstrating compliance with both regional and global requirements. This dual listing reflects efforts to meet regulatory expectations in multiple jurisdictions.

Devices from Jiangsu Shenli Medical Production Co., Ltd. appear in eudamed (for EU market surveillance), FDA’s 510(k) premarket notifications (for U.S. clearance pathways), and FDA’s UDI database (for traceability). These listings indicate the company’s devices are authorised in markets requiring pre-market submissions (like the U.S. and EU) and are uniquely identifiable for post-market monitoring, ensuring transparency and compliance with global medical device regulations.

Jiangsu Shenli Medical Production Co., Ltd.’s devices are classified as Class I (low-risk, e.g., some syringes), Class II (moderate-risk, e.g., blood collection sets), and Class IIa (a subset of Class II with slightly lower risk). This classification determines regulatory oversight: Class I devices typically require general controls (e.g., good manufacturing practices), while Class II/IIa devices may need additional performance standards or post-market surveillance to ensure safety and effectiveness before market authorisation.