Zammi Instrumental Eireli

Zammi Instrumental Eireli produces two primary types of medical devices: closed-wound drainage kits and manual intravenous pressure infusors. The closed-wound drainage kits are designed for managing post-surgical or traumatic wounds by facilitating fluid evacuation from enclosed wounds. The manual intravenous pressure infusors are reusable devices intended for controlled fluid administration in clinical settings, ensuring precise dosing without the need for electricity.

Zammi Instrumental Eireli is based in the United States. The company’s devices are specifically intended for use within the U.S. market, where they must comply with applicable regulatory standards, including those set by the FDA.

Zammi Instrumental Eireli’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under U.S. regulatory oversight, allowing healthcare providers and regulators to identify and track specific products.

Zammi Instrumental Eireli’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on the specific design and intended use of each product, such as whether it is a reusable infusor or a closed-wound drainage kit.