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U.S. FDA Medical Device Hospital Bassinet Requirements

FDA Medical Device Definition: A pediatric hospital bed is a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable and latchable side rails. The contour of the bed surface may be adjustable.

Registrar Corp assists Hospital Bassinet companies with:

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