KIRO GRIFOLS SL.

KIRO Grifols SL specializes in devices for sterile medication preparation and handling. Their portfolio includes intravenous solution compounders, such as automated systems for sterile preparation and dispensing (e.g., KIRO Fill US), as well as compounding transfer sets (e.g., KIRO Set) designed to enhance safety during medication transfer. Additionally, they offer non-clinical data monitoring software (e.g., KIRO Link) for tracking equipment performance, improving workflow efficiency, and supporting compliance in healthcare environments.

KIRO Grifols SL operates from the United States, where its devices must comply with FDA regulations. The company’s location means its products are subject to U.S. medical device authorization pathways, including classification under FDA’s Class I or Class II categories. This classification determines the regulatory controls applied to ensure safety and performance before market introduction.

Yes, KIRO Grifols SL’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency for healthcare providers, regulators, and other stakeholders, as required by FDA regulations for medical devices. This helps streamline tracking and compliance for authorized products.

KIRO Grifols SL’s devices fall under FDA’s Class I or Class II classifications, depending on their risk level and intended use. Class I devices generally pose minimal risk (e.g., some compounding accessories) and may require general controls, while Class II devices (e.g., automated compounders) involve moderate risk and may need special controls to ensure safety and effectiveness. Classification determines the regulatory pathway for authorization.

The non-clinical data monitoring software (e.g., KIRO Link) developed by KIRO Grifols SL is designed to track performance metrics and operational data for medical equipment *outside* direct patient care. It supports healthcare facilities by improving workflow efficiency, ensuring equipment maintenance records are up-to-date, and helping meet compliance requirements for device tracking and reporting—without interacting with clinical decision-making.