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U.S. FDA Medical Device Air Fluidized Bed Requirements

FDA Medical Device Definition: An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation

Registrar Corp assists Air Fluidized Bed companies with:

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