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FDA Device Registration Services
  1. Start the registration
  2. Complete information
  3. Get registration confirmation

TYPE OF REGISTRATION

OWNER, OPERATOR, OR AGENT-IN-CHARGE INFORMATION

Street Address, Line 1
City
State / Province
ZIP / Postal Code
Country

OFFICIAL CORRESPONDENT INFORMATION

U.S. Agent Street Address, Line 1
City
State / Province
ZIP / Postal Code
Country

FACILITY INFORMATION

Is this registration the result of buying a registered facility?

Facility Street Address, Line 1
City
State / Province
ZIP / Postal Code
Country

IMPORT INFORMATION

Does the facility import medical devices to the United States?

Manufacturer Street Address, Line 1
City
State / Province
ZIP / Postal Code
Country

PRODUCT INFORMATION

Is the device part of a combination product that includes a drug or biologic?

Select all activities related to this device that are performed at this facility.

The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form.By submitting this form to FDA, or by authorizing an individual to submit this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the registration on the facility’s behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the registration. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.

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