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U.S. Department of Health and Human Services

Product Classification

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Device led diodes sold as components to be installed in finished electronic products
Definition LEDs sold as components to be installed in finished electronic products, such as bare LED diodes and LED diode arrays without control or power modules or standard lamp fitting included. Not including finished bulbs or lamps.
Product CodeRIP
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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