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U.S. FDA Medical Device Ophthalmic Conformer Requirements

FDA Medical Device Definition: An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]

Registrar Corp assists Ophthalmic Conformer companies with:

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