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U.S. FDA Medical Device Sclera 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 Sclera Marker companies with:

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