FDA Medical Device Listing Certificate (Informational)
An FDA Medical Device Listing Certificate is an informational document designed to help medical device companies present their FDA registration and device listing credentials in a clear and professional format to clients, distributors, partners, or internal stakeholders.
These certificates are commonly used for business verification and informational purposes only.
Important FDA Disclosure
The U.S. Food and Drug Administration (FDA):
Does not issue certificates for medical device establishment registration or device listing
Does not endorse or recognize third-party certificates
Does not approve devices or establishments through certificates
Any certificate provided by FDA Registration Assistance is strictly informational and summarizes existing FDA registration and listing information.
Eligibility Requirements
FDA Registration Assistance issues FDA Medical Device Listing Certificates only for companies that already have:
An active FDA Medical Device Establishment Registration
Completed FDA Medical Device Listings
Certificates are not issued for:
Unregistered establishments
Inactive or incomplete FDA listings
Pending FDA submissions
All information included is verified against FDA records at the time of issuance.
FDA Medical Device Listing Certificate Services
Our certificate service allows you to:
Present FDA listing credentials professionally
Share verified information with business partners
Maintain organized compliance documentation
To have FDA Registration Assistance issue your FDA Medical Device Listing Certificate, please contact us today.
Frequently Asked Questions (FAQ)
What is an FDA Medical Device Listing Certificate?
It is an informational certificate summarizing a company’s FDA medical device establishment registration and device listing status.
Does the FDA issue or approve these certificates?
No. The FDA does not issue, approve, or recognize certificates for medical device listings.
What is the purpose of this certificate?
The certificate is used to display existing FDA registration and listing information to clients or partners.
Who is eligible to receive a certificate?
Only companies with active FDA Medical Device Establishment Registration and completed device listings.
Can the certificate be used as FDA approval?
No. The certificate does not replace FDA clearance, approval, or authorization (e.g., 510(k), PMA).
Can FDA Registration Assistance prepare the certificate for me?
Yes. FDA Registration Assistance prepares verified, professional Medical Device Listing Certificates for eligible clients.
Contact FDA Registration Assistance
Present your FDA medical device listing credentials clearly and professionally.
