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U.S. FDA Medical Device Urethral Sound Requirements

FDA Medical Device Definition: A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower

Registrar Corp assists Urethral Sound companies with:

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