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About Us
Our Services
- By Industry
- By Region
FDA REGISTRATION
Resources
- News and Articles
- EU Ingredients Compliance updates
Contact Us

About Us
Our Services
- By Industry
- By Region
FDA REGISTRATION
Resources
- News and Articles
- EU Ingredients Compliance updates
Contact Us

FDA MEDICAL DEVICE REGISTRATION FORM

1Establishment Details

2Establishment Contact

3US Importer / Distributor

4Device Listing Information

5US FDA Medical Device Registration Form Submitter Information

6Review

Establishment Name *

Address

Address Line 1

City

State / Province / Region

Postal Code

Country

FDA Registration Number *

DUNS Number *

LLC

I hereby authorize Cosmereg LLC to obtain duns number on our behalf for an additional fess of 100 USD

Name of Contact Person *

Job Title *

Address *

Address Line 1

City

State / Province / Region

Postal Code

Country

Tel Number *

Email *

Other Business Names *

Type of Operation

Manufacturer
Contract Manufacturer
Contract Sterilizer
Specification Developer
Initial Importer
Foreign Exporter
Relabeler
Other

Other (Explain) *

US Importer Name *

FDA Registration Number *

DUNS Number *

Address *

E-mail *

Tel Number *

Device Listing Information - 1

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Device Listing Information - 2

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Device Listing Information - 3

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Device Listing Information - 4

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Device Listing Information - 5

Proprietary Name

Common Name

Device Class

Device Code

510 (K) Number

Submitter Name *

Job Title *

Email *

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U.S Agent Terms and Condition

Terms and Conditions

I Agree terms and conditions mentioned above. *

US FDA Regulations

FDA MoCRA Cosmetic Regulations
U.S. FDA Drug Services
FDA food regulations
US FDA Dietary Supplement Regulations
USA Medical Devices
US FDA Agent

Health Canada Regulations

Cosmetic Regulations Canada
Natural Health Product (NHP) Regulations Canada
Canada Medical Devices

EU/UK Regulations

EU Cosmetic Regulations
CPSR (Cosmetic Product Safety)
EU UK Responsible Person

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