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FAQ

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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.

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

O sistema OnePacs é aprovado pela ANVISA para uso clínico no Brasil.

We self-certify compliance with:

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