About Us
The regulatory clearances, quality certifications and compliance declarations behind Erythros devices, with the original certificates on file.
Market authorisations that permit Erythros devices to be sold as medical devices in each region.
FDA registration and clearance confirms that our devices meet the rigorous safety and efficacy standards required for medical devices in the United States.
The FDA 510(k) clearance is a specific premarket submission made to the FDA to demonstrate that our device is safe and effective—substantially equivalent to a legally marketed device that is not subject to premarket approval.
The CE marking certifies that our products meet the European Union's health, safety, and environmental protection standards, allowing them to be sold throughout the European Economic Area.
The Medical Device Licence (MDL) authorizes the sale of our devices in Canada, confirming they meet Health Canada's safety, effectiveness, and quality requirements.
The TGA certification confirms that our devices meet the rigorous health and safety standards required for therapeutic goods in Australia.
Audited quality systems covering how our devices are designed, manufactured and monitored after sale.
ISO 13485 represents the gold standard in medical device quality management systems. It's more than a certification—it's our commitment to excellence in every device we produce.
MDSAP allows for a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Declarations that the devices meet electromagnetic and environmental standards.
RoHS compliance ensures our products are free from harmful substances like lead, mercury, and cadmium, demonstrating our commitment to environmental protection and user safety.
The FC Declaration of Conformity certifies that our devices meet regulatory requirements for electromagnetic emissions and immunity, ensuring they operate safely without causing harmful interference.