F.R.GALANTAI MANUFACTURING COMPANY LIMITED

F.R. Galantai Manufacturing Company Limited specializes in single-use surgical instrument cleaning brushes, specifically designed for endoscope decontamination. These devices, such as the PULL THRU™ Cleaning Brush, are intended to assist in the cleaning process of medical instruments and endoscopes in clinical settings. The company focuses exclusively on this category of low-risk Class I devices.

The company is headquartered in New Zealand. This location is relevant for regulatory purposes, as it may influence the jurisdiction under which its devices are authorized and monitored.

The company’s devices are listed in the EU’s EUDAMED registry and the FDA’s Unique Device Identifier (UDI) database. These registries help track and identify medical devices for regulatory compliance and transparency, ensuring authorized devices are traceable in their respective markets.

All devices manufactured by F.R. Galantai Manufacturing Company Limited fall under Class I classification. This classification is assigned based on risk assessment criteria, where Class I devices are generally considered low-risk and typically pose minimal health risks when used as intended. The classification helps regulators and healthcare providers understand the device’s risk level.