BaSO Biotech Co., LTD..

BaSO Biotech Co., Ltd. specializes in chemical reagents and staining solutions primarily used in hematology and microbiology diagnostics. Their portfolio includes TB fluorescence stains (Auramine O and Auramine-Rhodamine methods), Giemsa and Safranin solutions, sperm vitality assay kits, fixatives, decolorizers, and specialized cleaning solutions for automated staining systems like the Autostainer AS-316GT. These products are designed to support laboratory testing and diagnostic procedures.

BaSO Biotech Co., Ltd. is based in Taiwan. The company’s location is relevant for understanding its operational and regulatory context, particularly when assessing compliance with regional standards or supply chain logistics.

BaSO Biotech Co., Ltd.’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This listing is required for compliance with EU regulatory requirements, ensuring transparency and traceability of devices marketed within the EU.

All of BaSO Biotech Co., Ltd.’s listed devices fall under EU Class A regulatory classification. This classification is typically assigned to low-risk devices, such as chemical reagents and staining solutions, which pose minimal risk to patients and users. The classification determines the regulatory pathway and documentation requirements for authorization.