Medical Device Registration.
The GUDID Engine. We handle your Establishment Registration, Device Listing, and UDI submission in one integrated workflow. FY 2026 Ready.
Blocked by the GPO Wall?
Hospital procurement systems (Premier, Vizient) automatically reject devices without a GUDID record. Your UDI-DI is your passport to the U.S. healthcare market.
Procurement Error
Vizient Catalog Sync Failed
Before you list:
510(k) Clearance
Most Class II devices require Premarket Notification (510k) before registration. Listing without clearance is a prohibited act.
If your device is not 510(k) exempt, you must receive a Substantial Equivalence (SE) letter from FDA before you can legally market it. We help you find the right predicate device and prepare your submission.
Predicate Search
AI-powered search of FDA's 510(k) database to find your substantial equivalent.
Exemption Check
Verify if your product code falls under the 510(k) exemption list.
Listing Sync
Automatically link your K-Number to your device listing upon clearance.
The risk of administrative destruction
New FDA authority allows customs to destroy refused devices valued under $2,500 without returning them to you.
Immediate Destruction
FDA can now destroy refused devices at the port of entry. No return. No second chance.
Detention Without Exam
If your GUDID listing is missing, your shipment is automatically held. Storage fees average $800/day.
Import Alert 89-08
Devices from non-compliant facilities are added to the Red List. Requires expensive 3rd party certification to remove.
Pay $2,320 instead of $9,280.
Most medical device startups qualify as a “Small Business” (under $100M gross sales). FDA doesn't give you this discount automatically—you must apply for it. We handle the MDUFA Small Business Certification (Form FDA 3602) to save you 75% on user fees.
Quality is your
Operating System.
21 CFR 820 isn't just a rulebook—it's the blueprint for safe manufacturing. We build your digital Quality Management System (eQMS) from Day 1, ensuring every design change and risk analysis is traceable, locked, and audit-ready.
Design Controls (DHF)
Full traceability matrix linking inputs to outputs.
Risk Management
ISO 14971 compliant hazard analysis built-in.
Audit Defense
One-click export for FDA inspectors. No paper binders.
We generate your UDI barcodes.
Stop wrestling with GS1 standards manually. We generate compliant UDI-DI and UDI-PI barcodes (1D and 2D) ready for your label printer.
- GS1 & HIBCC Compatible
- GUDID Database Sync
- Label Validator (21 CFR 801)
- Direct-to-Print Format
MEDI-SCAN™
Foreign Facility?
You must appoint a US Agent.
If your establishment is outside the United States, you cannot register without a designated U.S. Agent. We serve as your official communication bridge with the FDA, available 24/7 for emergency response.
The Full Compliance Stack
Medical device regulation is layered. We handle every level.
Unlock Global
Markets.
To sell your US-registered device in Europe, Asia, or Latin America, you need a Certificate to Foreign Government (CFG). We handle the entire FDA application.
Certificate to Foreign Government (CFG)
For devices legally marketed in the US.
Certificate of Exportability (COE)
For devices 801(e)(1) or 802 compliant but not sold in US.
Notary & Apostille
Full legalization services for Hague Convention countries.
The Registration Evolution
Stop fighting 2003-era government portals.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.