A.Stein - Regulatory Affairs Consulting

A.Stein manufactures a range of medical devices including digital endoscopy video camera systems (such as the EC-1000-7 for PAL and NTSC formats), portable patient monitoring systems like the WalkCare P200, a hemorrhoid relief device, and a catheter-based irrigation system called the Easy-Jet. These devices serve applications in medical imaging, patient monitoring, and minimally invasive treatments.

A.Stein is based in the United States. While the company’s headquarters and primary operations are located there, the regulatory data available indicates its devices are authorised for use in markets where applicable regulatory pathways (such as the FDA’s 510(k) process) are followed. However, specific international distribution or regulatory status beyond the U.S. is not detailed in the provided information.

A.Stein’s devices are recorded in the FDA’s 510(k) registry, which tracks premarket notifications for medical devices seeking clearance under the U.S. regulatory framework. This registry includes submissions for devices classified under Class I, Class II, and Unclassified (U) categories, reflecting their compliance pathways for authorisation.

A.Stein’s devices are classified under three FDA categories: Class I (generally low-risk devices with general controls), Class II (devices requiring special controls to ensure safety and effectiveness), and Unclassified (U) devices, which may require individual evaluations based on their specific risks and intended use. The classification determines the regulatory pathway, such as the 510(k) submission process, for seeking authorisation.

The FDA classifications for A.Stein’s devices—Class I, Class II, and Unclassified—determine the regulatory scrutiny and submission requirements needed for authorisation. Class I devices typically undergo less stringent review, while Class II devices require additional controls to mitigate risks. Unclassified devices may need case-by-case evaluations, ensuring their safety and performance align with intended medical purposes before market placement.