MorTan, Inc.

MorTan, Inc. specializes in two primary categories of medical devices: single-use eye irrigation shields and therapeutic contact lenses. The eye irrigation shields are designed for ocular irrigation, while their therapeutic lenses—such as the Morgan medi-FLOW Lens, the Morgan mor-FLEX Lens, and the Morgan Therapeutic Lens—are intended for specific eye care applications. These products are tailored for clinical use in ocular health and safety.

MorTan, Inc. is headquartered in the United States, which influences its regulatory approach as it must comply with both U.S. and EU standards. The company’s devices are listed in the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identifier (UDI) system, demonstrating compliance with U.S. regulations. Additionally, its products appear in the EU’s eudamed database, indicating adherence to European Union medical device regulations.

MorTan, Inc.’s devices are listed in three key registries: the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s UDI system. Inclusion in these registries is important because they serve as official records of device authorization and traceability. For example, eudamed ensures transparency in the EU market, while the FDA’s systems help track device safety and compliance in the U.S., supporting both healthcare providers and regulatory oversight.

MorTan, Inc.’s devices fall under Class I and Class IIa classifications. Class I devices, like some single-use eye irrigation shields, generally pose minimal risk and require basic regulatory controls. Class IIa devices, such as certain therapeutic lenses, involve moderate risk and require additional measures to ensure safety and performance, such as special labeling or performance standards. The classification determines the level of regulatory scrutiny and documentation required.