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HomeMedical Devices › U.S. FDA UDI Requirements

U.S. FDA Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID) Requirements

The U.S. FDA requires medical device labelers to:
  • Include Unique Device Identifiers (UDI) on their device labels
  • Submit device information to the Global Unique Device Identification Database (GUDID)
  • Designate a Regulatory Contact for UDI purposes
Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements.

For assistance with new FDA UDI and GUDID requirements, simply complete the form below.

 I would like assistance determining if FDA's new UDI requirements apply to my device.
 I would like more information about Registrar Corp's Regulatory Contact service.
 I would like assistance submitting information to FDA's GUDID.
Company Name: *
Contact Name: *
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Country: *
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  We may be registered but I cannot recall our Registration Number
Type of Business (Select all that apply):
Manufacturer - Owns or operates a facility that manufactures a device.
Importer - Engaged in importing a device into United States.
Distributor - Engaged in distributing a device.
Labeler - Any person who causes a label to be applied to a device.
Other - Please specify:

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U.S. FDA Regulations:

UDI-GUDID Regulations: 78 Fed. Reg. 58785, 58785-58828


 


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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