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U.S. FDA Medical Device Corrugated Rubber Sheath Requirements


FDA Medical Device Definition: A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection.

Registrar Corp assists Corrugated Rubber Sheath companies with:

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