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U.S. FDA Medical Device Manual Stethoscope Requirements

FDA Medical Device Definition: A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Registrar Corp assists Manual Stethoscope companies with:

  • FDA Manual Stethoscope Establishment Registration
  • FDA Manual Stethoscope Listing
  • FDA Manual Stethoscope Label Requirements and Exceptions
  • FDA Manual Stethoscope Import Information
  • FDA Manual Stethoscope Detentions (Manual Stethoscope Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Manual Stethoscope Manufacturers (Manual Stethoscope Suppliers)
       - Manual Stethoscope Distributors
       - Manual Stethoscope Processors
       - Manual Stethoscope Repackers
       - Manual Stethoscope Relabelers
       - Manual Stethoscope Exporters
       - Manual Stethoscope Importers
For more information about Manual Stethoscope Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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