CELITRON Medical Technologies Ipari es Szolgaltato Korlatolt Felelossegu Tarsasag

CELITRON Medical Technologies specializes in producing steam sterilizers, such as the Belimed model. These devices are engineered for medical and dental facilities to safely sterilize instruments and equipment using steam, ensuring compliance with infection control standards.

CELITRON Medical Technologies is based in the United States, which means its devices are subject to FDA regulations. The company’s steam sterilizers fall under Class II classification, indicating they pose moderate risks and require special controls to ensure safety and performance before entering the market.

Yes, CELITRON’s steam sterilizers, including the Belimed model, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle, ensuring traceability, recall management, and compliance with post-market surveillance requirements.

CELITRON’s steam sterilizers are classified as Class II devices by the FDA. This classification means they are considered to have a moderate risk to patients and require special controls beyond general controls (like good manufacturing practices) to mitigate risks. These controls may include performance standards, post-market surveillance, or labeling requirements to ensure safe and effective use.