Altris, Inc.

Altris, Inc. specializes in diagnostic imaging devices for ophthalmology. Their portfolio includes the Macula Explorer, designed for detailed retinal imaging, the Altris IMS for intraocular imaging, and the Altris handheld system, which focuses on anterior segment and corneal analysis. These devices are developed to assist in precise visual diagnostics.

Altris, Inc. is headquartered in the United States. This location influences its regulatory pathways, as the company’s devices are cleared through the FDA’s 510(k) process, which is specific to US regulatory requirements. Additionally, some of their devices are listed in the EU’s eudamed registry, indicating compliance with European Union medical device regulations.

Altris, Inc.’s devices are listed in the EU’s eudamed registry and cleared via the FDA’s 510(k) pathway. Listing in eudamed ensures visibility and traceability of devices within the European market, while FDA 510(k) clearance confirms compliance with US safety and performance standards. These registries help healthcare providers and regulators verify the authorised status of specific devices.

Altris, Inc.’s devices fall under Class II and Class IIa classifications. These classifications are determined by risk levels and intended use. Class II devices typically involve moderate risk and require special controls beyond general controls, while Class IIa devices are considered lower risk but still require additional regulatory oversight to ensure safety and effectiveness.