FDA Medical Device Registration Form

Establishment

Establishment Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

FDA Registration Number

DUNS/EIN Number

Establishment Contact

Contact Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email *

Phone *

Other Business Names

Other Type of Operation

US Importer/Distributor (For Foreign Facility Only)

US Importer Name

FDA Registration Number

DUNS Number

Address

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email

Phone

Manufacturer (For US Facility Only)

Manufacturer Name

FDA Registration Number

Listing Number

Address

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email

Phone

Medical Device(s)

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Register Another Medical Device?

Yes
No

FDA Medical Device Registration Form

Who needs FDA medical device registration?

Establishment

Establishment Contact

US Importer/Distributor (For Foreign Facility Only)

Manufacturer (For US Facility Only)

Medical Device(s)