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U.S. FDA Medical Device Scanning Bed Requirements

FDA Medical Device Definition: A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

Registrar Corp assists Scanning Bed companies with:

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