FDA Medical Device Registration Form

Authority21 U.S.C. §360; 21 CFR Part 807 SubmittalAnnual — Oct 1 – Dec 31 OMB0910-0625 Required forAll device establishments

Establishment

Contact

Operation

US Importer

Manufacturer

Devices

Certification

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Establishment Information

Legal name and address of the registered facility

Establishment Name *

Street Address *

City *

State / Province *

Country *

Postal Code *

FDA Registration Number (if previously registered)

DUNS / EIN Number

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Establishment Contact

Primary contact person for this registration

Name of Contact Person *

Job Title *

Mailing Address *

City *

State / Province *

Country *

Postal Code *

Tel Number * (incl. country code)

E-Mail Address *

Other Business Names (DBA, trade names, etc.)

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Type of Operation

Select all operations performed at this establishment

Check all that apply *

Manufacturer Contract Manufacturer Contract Sterilizer Specification Developer Initial Importer Foreign Exporter Relabeler Other (Explain)

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US Importer / Distributor

For foreign facilities only

Complete this section only if your facility is located outside the United States. The U.S. importer/distributor must have a place of business within the United States.

US Importer Name

FDA Registration Number

DUNS Number

Address

E-Mail

Tel Number (incl. country code)

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Manufacturer

For US facilities only — if different from establishment

Complete this section only if your facility is located within the United States and manufacturing is performed at a different location.

Manufacturer Name

FDA Registration Number

Listing Number

Address

E-Mail

Tel Number (incl. country code)

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Medical Device Listing

List all medical devices manufactured, processed, packed or held at this establishment

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Certification Statement

The owner, operator, or agent in charge of this establishment certifies that the information provided on this form is true and accurate. Submission of false information to the U.S. Government may subject the submitter to criminal penalties under 18 U.S.C. §1001. Registration does not constitute FDA approval or clearance of any medical device.

Name of Authorized Official *

Title / Position *

Signature (typed) *

Date of Submission

I certify that the above information is true, accurate, and complete to the best of my knowledge. *

Medical Device Registration

Establishment Information

Establishment Contact

Type of Operation

US Importer / Distributor

Manufacturer

Medical Device Listing

Certification Statement

Registration Submitted