Geneoscopy, Inc.

Geneoscopy, Inc. specializes in faecal specimen collection kits designed for home use as in vitro diagnostics (IVDs). These devices are primarily intended for collecting stool samples, which can then be used for diagnostic testing, such as colorectal cancer screening. The company’s focus is on enabling convenient, at-home sample collection for laboratory analysis.

Geneoscopy, Inc. is based in the United States. Since it operates within the US market, its devices are subject to FDA regulations. The company’s products fall under the jurisdiction of the FDA, which oversees their compliance with requirements like Premarket Approval (PMA) and Unique Device Identification (UDI) for Class III devices.

Geneoscopy, Inc.’s faecal specimen collection kits are classified as Class III medical devices under US regulations. This classification is the highest risk tier, typically reserved for devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Due to this classification, the devices require rigorous premarket approval (PMA) to ensure safety and effectiveness before they can be marketed.

Geneoscopy, Inc.’s devices are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) databases. These registries ensure transparency and traceability of medical devices, allowing healthcare providers, regulators, and patients to access critical information about authorised products, including their approval status, identification details, and compliance with regulatory requirements.