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U.S. FDA Medical Device Vacuum Regulator Requirements

FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Registrar Corp assists Vacuum Regulator companies with:

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