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U.S. FDA Medical Device Haploscope Requirements

FDA Medical Device Definition: A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).

Registrar Corp assists Haploscope companies with:

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