Suzhou Changhe Biotech Co., Ltd.

Suzhou Changhe Biotech Co., Ltd. specializes in miniaturized polymerase chain reaction (PCR) devices. These instruments are designed for nucleic acid amplification testing, enabling rapid and portable molecular diagnostics. They are intended for use in clinical and research settings, particularly for point-of-care or field-based applications.

The company is headquartered in Suzhou, China. This location reflects its operational base for manufacturing and regulatory compliance, though its devices may be distributed globally depending on market needs.

The company’s mini PCR devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices placed on the EU market, ensuring transparency and traceability.

Under EU medical device regulations, Suzhou Changhe Biotech Co., Ltd.’s mini PCR devices fall under Class A risk classification. This classification is determined based on the device’s intended purpose and potential risks, with Class A representing the lowest risk category for devices like diagnostic accessories or simple diagnostic tools.