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Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. Class II General Controls and Special Controls With Exemptions Without Exemptions 3....

Condom - Wikipedia

    https://en.wikipedia.org/wiki/Condom

    Condoms: Birth Control, Types, How They Work

      https://my.clevelandclinic.org/health/drugs/9404-condoms
      A condom is a thin, loose-fitting pouch or sheath that protects against sexually transmitted diseases (STDs) or infections (STIs). As a barrier method of birth control (contraception), …

    FDA Condom Quality Control for Class II …

      https://www.condomjungle.com/blog/fda-condom-quality-control/
      There are three classifications for medical devices, and yes, the FDA considers a condom a “medical device”. Medical devices are Class I, II or III. The level of classification depends on the …

    What Is a Condom? - Verywell Health

      https://www.verywellhealth.com/what-is-a-condom-5085003

      FDA Approved Condoms - What Does FDA …

        https://www.ripnroll.com/collections/fda-approved-condoms
        Condoms are medical devices? Condoms are regarded by the United States Food and Drug Administration (FDA) as “Class II medical devices”, this designation also includes pregnancy …

      Medical Devices | Definition, categories and classification

        https://www.eurofins.com/consumer-product-testing/industries/medical-devices/what-is-a-medical-device/
        Under the MDR, there 3 major categories for medical devices: Non-invasive devices (1-4); Invasive medical devices (5-8); Active medical devices (9-13); Special Rules (14-22). Classification …

      Product Classification - Food and Drug Administration

        https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=peb
        A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural …

      Product Classification - Food and Drug Administration

        https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&Submission_Type_ID=&DeviceName=condom&ProductCode=&DeviceClass=&Panel=&RegulationNumber=&sortcolumn=DeviceClassDESC
        10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

      Complete Guide: Medical Device …

        https://easymedicaldevice.com/new-eu-medical-device-classification/
        Let me provide you with some medical device classification examples in Europe for each class: Class I: Wheelchair, otoscope, stethoscope, scalpel, plaster Class I …



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