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U.S. FDA Medical Device Ocular Marker Requirements

FDA Medical Device Definition: An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

Registrar Corp assists Ocular Marker companies with:

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