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Miscellaneous

Certifications and Registrations

The OnePacs System is 510(k) cleared by the US Food and Drug Administration as a class II medical device. OnePacs satisfies the requirements of the FDA for manufacturers of Class II devices, including Establishment Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulation (21 CFR Part 820), and other regulations.

 According to the guidelines stated in Directive 93/42/EEC of the European Community, the OnePacs system distributed in the EU is a Class I Medical Device. OnePacs satisfies the requirements for bearing the CE mark on its labeling.

The OnePacs system is cleared for medical use in Brazil under the ANVISA program.

We self-certify compliance with:

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