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U.S. FDA Medical Device Urethrometer 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 Urethrometer companies with:

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