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U.S. FDA Medical Device Roller Apparatus Requirements

FDA Medical Device Definition: Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

Registrar Corp assists Roller Apparatus companies with:

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