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U.S. FDA Medical Device Hydrophilic Beads Requirements

FDA Medical Device Definition: A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Registrar Corp assists Hydrophilic Beads companies with:

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