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U.S. Department of Health and Human Services

Product Classification

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Device uv curing
Definition An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.
Product CodeRGO
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting
Ineligible
Third Party Review Not Third Party Eligible
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