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U.S. FDA Medical Device Noninvasive Tubing 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 Noninvasive Tubing companies with:

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