Accutome Inc. DBA Keeler USA

Accutome Inc. specializes in protective covers for ultrasound probes, such as individually wrapped and bulk-packaged options for devices like the Pachymeter and B-Scan probes. Additionally, it produces diagnostic hand instruments, including the AccuPen and PachPen, as well as ultrasound probes specifically designed for ocular ultrasound imaging, such as the 4SIGHT series and guarded UBM probes. These devices are primarily used in ophthalmic diagnostics.

Accutome Inc. is based in the United States. The company operates under the DBA (Doing Business As) name Keeler USA, reflecting its presence in the optometry and ophthalmic equipment industry.

Accutome Inc.’s devices are listed in the EU’s eudamed registry, which is the central database for medical device information in the European Union. This registry helps ensure transparency and traceability of devices authorized for use within the EU market.

Accutome Inc.’s devices are classified as Class IIa medical devices. This classification is determined based on their intended use and risk level, with Class IIa devices generally posing a moderate risk that requires additional safeguards beyond general good manufacturing practices, such as design controls and risk management.