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This article applies to selling in: India

Finger Pulse Oximeter

Important: If you sell products on Amazon, you must comply with all applicable laws and Amazon Policies for product listings that may be revised from time to time.

A pulse oximeter is a small, lightweight device used to monitor the amount of oxygen carried in the body. This noninvasive tool attaches painlessly to your fingertip, sending two wavelengths of light through the finger to measure your pulse rate and how much oxygen is in your system. Once the oximeter finishes its assessment, its screen will display the percent of oxygen in your blood —and your current pulse rate.

Amazon India require that Finger Pulse Oximeter listed for sale on Amazon meets following requirements. In order to sell these products on Amazon, you must apply and submit the following to

  1. Company name
  2. Seller/Vendor ID
  3. Registered Email address
  4. A list of Finger Pulse Oximeter ASINs you are applying to sell.
  5. Images of the product displaying importer/manufacturer information, brand, model number and safety marking (applicable for complied CE certification)
  6. Documentation is required to confirm the product was tested and should comply with the below requirements.
Product Requirements
Finger Pulse Oximeter
  • CE Marking from a European notified body
    • Or
  • FDA 510(K) Pre-market notification
    • Or
  • Test report as per the below given standards for the applicable product models from ILAC (or) NABL accredited 3rd party test labs.
    • - IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
    • - IEC 60601-1-2 – Medical electrical equipment – Electromagnetic Interference (EMI)/Electromagnetic compatibility (EMC) requirements. (Optional)
    • - IEC 60601-1-6 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    • - IEC 60601-1-11 – Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    • - ISO 80601-2-61 – Medical electrical equipment - Part 2-61: Particular requirements for pulse oximeter equipment
    • - ISO 10993 - Biological evaluation of medical devices

You declare and represent that all the documents you submit are true, authentic, and accurate. Amazon may remove your selling privileges for failing to meet the above requirements within the specified timelines.

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