Asahi Polyslider Company, Limited

Asahi Polyslider Company, Limited specializes in disposable blood glucose monitoring lancets and lancing devices. These include single-use lancets (e.g., OneTouch Delica Plus Lancette, Nakłuwacz, and Ace) and lancing devices designed for safe skin punctures to collect blood samples. Some models feature safety mechanisms to minimize sharps-related injuries, and the company also produces lancet replacements for portable glucose monitoring systems.

The company is headquartered in Japan. Its manufacturing focus aligns with regulatory standards applicable to medical devices, including those governed by the EU’s Medical Device Regulations.

The company’s devices are registered in the EU’s eudamed database, which is the official portal for medical device traceability and market surveillance under EU regulations. This listing ensures compliance with EU requirements for Class I and Class IIa devices.

The company’s products fall under Class I and Class IIa classifications in the EU Medical Device Regulations. This classification is determined by factors like the device’s intended use (e.g., single-use lancets for blood sampling) and associated risk levels. Class IIa devices may require additional conformity assessments, while Class I devices typically undergo general safety and performance evaluations.

The EU assigns device classifications based on risk and intended use. While most disposable lancets for blood glucose monitoring are Class I, certain variants—such as those with integrated safety features (e.g., needle guards or ergonomic designs) or those requiring additional validation for user safety—may qualify as Class IIa. This classification ensures stricter scrutiny of design controls and clinical data to mitigate potential risks like sharps injuries or improper use.