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U.S. FDA Medical Device Distometer Requirements

FDA Medical Device Definition: A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.

Registrar Corp assists Distometer companies with:

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