Ningbo Advan Electrical Co., Ltd.

Ningbo Advan Electrical Co., Ltd. specializes in non-bioabsorbable skin staplers and single-use skin staple removers. These devices are used in surgical settings to close wounds by securing skin layers and to safely remove staples after procedures. The focus is on one-time-use solutions for wound closure and post-operative care.

The company is based in China. Its devices are designed to comply with international regulatory standards, which is why they appear in global registries like EUDAMED (for EU market access) and the FDA’s UDI system (for traceability in the US). This reflects the company’s commitment to meeting regulatory requirements across different markets.

Devices from Ningbo Advan Electrical Co., Ltd. are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI system (for unique device identification in the US). These listings ensure transparency and traceability, allowing healthcare providers and regulators to verify device details, compliance status, and market authorization where applicable.

The company’s devices fall under Class I and Class IIa classifications. Class I devices are generally low-risk, such as basic surgical instruments, while Class IIa devices involve a moderate level of risk, like certain wound closure tools. Classification determines regulatory scrutiny and post-market requirements, ensuring appropriate oversight based on device risk.