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U.S. FDA Medical Device Heating Block Requirements


FDA Medical Device Definition: General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Registrar Corp assists Heating Block companies with:

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