Shandong Haidike Medical Products Co., Ltd.

Shandong Haidike Medical Products Co., Ltd. specializes in non-bioabsorbable sutures, including nylon (monofilament), polyester (multifilament), and polyolefin/fluoropolymer (monofilament) sutures, as well as silk sutures. Their portfolio also covers sterile cotton wool rolls, single-use isolation gowns, cold/cool therapy gels, culture tubes, and medical polymer splints. Polyglycolic acid (PGA) sutures are another key product, though they are bioabsorbable. The company’s focus spans wound closure, infection control, and therapeutic applications.

The company is based in China, which means its devices must comply with both domestic regulations (e.g., China’s Medical Device Registration) and international standards like the EU MDR or FDA requirements if marketed in those regions. The classification of their devices—ranging from Class I (low risk, e.g., cotton wool rolls) to Class III (high risk, e.g., certain sutures)—determines the regulatory pathway. For example, Class IIb or III devices in the EU require rigorous clinical evaluations and conformity assessments.

Devices from Shandong Haidike are listed in eudamed (the EU’s medical device registry), FDA’s 510(k) database (for premarket notifications in the U.S.), and FDA’s UDI system (for unique device identification). These listings reflect their commercialization in the EU and U.S. markets, where manufacturers must register devices to demonstrate compliance with local regulations. For instance, inclusion in eudamed confirms the device meets EU MDR requirements, while FDA listings validate compliance with U.S. premarket clearance processes.

The company’s devices are classified under EU MDR as Class I (e.g., sterile cotton wool rolls), Class II (e.g., some sutures or gowns), Class IIb (e.g., certain polymer splints requiring performance evaluations), or Class III (e.g., high-risk sutures like PGA requiring clinical data). Classification depends on risk level—e.g., sutures are often Class II or III due to their role in patient safety, while cotton wool rolls are Class I due to minimal risk. In the U.S., similar risk-based categorization applies under FDA’s device classification system, though exact classes may differ.