FDA MEDICAL DEVICE REGISTRATION FORM

Establishment

Establishment Name*

Street Address*

City*

State*

Country*

Postal Code*

FDA Registration Number

DUNS / EIN Number

Establishment Contact

Name of Contact Person*

Job Title*

Mailing Address*

City*

State*

Country*

Postal Code*

Tel Number*

E-Mail*

Other business Names

Type of Operation

Manufacturer

Contract Manufacturer

Contract Sterilizer

Specification Developer

Initial Importer

Foreign Exporter

Relabeler

Other (Explain)

US Importer / Distributor (For Foreign Facility Only)

US Importer Name

FDA Registration Number

DUNS Number

Address

E-mail

Tel Number

Manufacturer (For US Facility Only)

Manufacturer Name

FDA Registration Number

Listing Number

Address

E-mail

Tel Number

Medical Device - 1

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Medical Device - 2

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Medical Device - 3

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Medical Device - 4

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Medical Device - 5

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Medical Device - 6

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Description of Service and Cost

Description of Service	Fees	Number of services	Total Fees
Establishment Registration, US Agent/Official Correspondent.	USD 449.00 (Annually)	Please Enter	$
Device Listing (additional devices)	USD 50/device	Please Enter	$
Label Review	USD 649/device	Please Enter	$
FDA Registration Fee for the Year 2025	USD 9,280.00	Pay directly to FDA	------
		Total	$

I agree to the above Terms and Conditions

Submitter Name*

Job Title*

Submitter E-mail*