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U.S. FDA Medical Device Ophthalmic Eye Shield Requirements


FDA Medical Device Definition: An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

Registrar Corp assists Ophthalmic Eye Shield companies with:

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