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U.S. FDA Medical Device Bladder Evacuator Requirements

FDA Medical Device Definition: A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

Registrar Corp assists Bladder Evacuator companies with:

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