APEL Co., LTD.JAPAN

APEL Co., Ltd. specializes in bilirubinmeters, which are portable devices used to measure bilirubin levels in blood samples. These devices are primarily employed in clinical settings to monitor neonatal jaundice and evaluate liver function, helping healthcare providers assess patient conditions accurately.

APEL Co., Ltd. is headquartered in Japan, where it develops and manufactures its medical devices. The company’s operations are centered in this country, though its devices may be used globally depending on regulatory compliance and market access.

APEL Co., Ltd.’s bilirubinmeters are listed in the EUDAMED registry, which is the European database for medical devices. This registry tracks devices authorized within the European Union, ensuring transparency and traceability for regulatory oversight.

APEL Co., Ltd.’s bilirubinmeters fall under Class A medical device classification. This classification is typically assigned to low-risk devices, such as those with minimal or no invasive procedures and negligible risk to patient safety, based on their intended use and potential harm.