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U.S. FDA Medical Device Mechanical Urinometer 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.

Registrar Corp assists Mechanical Urinometer companies with:

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