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U.S. FDA Medical Device Electrical 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 Electrical Urinometer companies with:

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