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U.S. FDA Medical Device Uroflowmeter Requirements

FDA Medical Device Definition: A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter. Urological_Bougie=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 Uroflowmeter companies with:

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