FDA GUDID Compliance
Medical devices sold in the U.S. must carry a Unique Device Identifier (UDI). These identifiers are submitted to FDA’s Global Unique Device Identification Database (GUDID) to create a system of traceability for medical devices in the market.
At USAgentPros, we help device companies meet FDA’s UDI and GUDID submission requirements quickly and accurately.
What is GUDID?
The Global Unique Device Identification Database (GUDID) is FDA’s system for collecting and maintaining device identification data. It allows regulators, healthcare providers, and patients to track and identify medical devices.
Our GUDID Services
- UDI compliance review and data preparation
- GUDID account setup and management
- Submission of device identifiers to FDA
- Ongoing updates and maintenance of GUDID entries
Why It Matters
Failure to comply with UDI/GUDID requirements can lead to:
- Shipment refusals or import delays
- FDA enforcement actions
- Reduced trust from healthcare partners
Why Device Companies Trust USAgentPros
Dedicated Compliance Pro – Guidance from setup through submission
Fast Turnarounds – Keep devices on the U.S. market without delay
100% Money-Back Guarantee – Confidence in every project
Competitive Pricing – Compliance made affordable
Meet FDA GUDID Requirements with Confidence
Don’t risk noncompliance with UDI or GUDID. Partner with USAgentPros for smooth, accurate submissions.