EUDAMED vs FDA GUDID: how the EU and US device databases differ

The short answer: GUDID is a device catalogue; EUDAMED is a device catalogue plus a company register plus a certificate register. Both hold UDI device-identifier records, and a team that has filed one often assumes the other is the same shape with different field names. It is not — and the differences change what you can look up, what you have to file, and what a gap in the data actually means.

They are answering different questions

GUDID — the Global Unique Device Identification Database — is the FDA's reference catalogue for devices carrying a UDI. Its job is device identification: given a device identifier, tell me what this device is. The public front door is AccessGUDID, run with the US National Library of Medicine.

EUDAMED is set up under Article 33 of the MDR (Regulation (EU) 2017/745) as a database integrating six distinct electronic systems, of which device registration is only one. Alongside it sit actor registration, notified bodies and certificates, market surveillance, and — still in development — vigilance and clinical investigations.

That structural difference is the source of nearly every other one.

The seven differences that matter

1. Companies. EUDAMED registers economic operators and assigns each an SRN. Search the registered actors and you get manufacturers, authorised representatives, importers and system/procedure-pack producers. GUDID has no equivalent — the FDA handles establishments through its own separate Establishment Registration and Device Listing system, not through GUDID. If you are doing supplier due diligence, this is the single biggest gap between the two.

2. Certificates. EUDAMED records the certificates issued by notified bodies, and most of that is public — you can read the indexed certificate records and trace each to its issuing body. GUDID holds no certificates; the US route is clearance or approval, a different mechanism with a different public record.

3. The family key. The EU has the Basic UDI-DI — a family identifier grouping device models that share intended purpose, risk class and essential design, and the key that certificates and declarations reference. GUDID has no equivalent. Coming from the US, this is the concept most often missed, and getting the family boundary wrong is expensive to unwind.

4. Nomenclature. EUDAMED uses the EMDN, published by the Commission free of charge and required by Article 26 MDR — see the Commission's EMDN pages. GUDID uses GMDN. The two are different vocabularies with different structures — there is no clean one-to-one mapping, and a device's EMDN term is not derivable from its GMDN code. (For how an EMDN code is built, see what is an EMDN code.)

5. Issuing entities. The EU designates four: GS1, HIBCC, ICCBBA and IFA. The FDA accredits three — GS1, HIBCC and ICCBBA. IFA is the EU-only one. In practice, a manufacturer using GS1 in both markets is unaffected; one using IFA in Germany has to think about the US separately. (On picking between the four, see which UDI issuing entity should you use.)

6. Where each sits in the process. EU device registration under Article 29 happens before the device is placed on the market, and it is a registration duty in its own right — the result is the indexed device corpus. In the US, GUDID submission accompanies the UDI labelling requirement — the market-authorisation question is handled elsewhere entirely.

7. What "not found" means. In GUDID, an absent record usually means the device is not UDI-labelled or is out of scope. In EUDAMED, absence has more possible causes — a legacy device, a device still inside the November 2026 grace period for pre-existing portfolios, or a certificate its notified body has not yet uploaded under the May 2027 deadline. Absence is weaker evidence in EUDAMED than in GUDID, and reading it as non-compliance is the classic error.

The one thing neither of them holds

Neither database stores production-identifier values. No lot numbers, no serial numbers, no expiry dates — not in GUDID, not in EUDAMED. GUDID carries flags indicating which PI attributes appear in a device's UDI, but not the values themselves.

This trips up teams building traceability expectations on top of the public registries. The UDI-DI tells you which model; the UDI-PI tells you which unit, and it lives on the label and in your own systems. If you need to trace a specific lot, the answer is in your records, not in a public database — in either jurisdiction.

If you file in both markets

Three practical notes for a team maintaining both:

• Do not treat EU registration as a translation of your GUDID submission. The Basic UDI-DI, the EMDN term and the actor chain have no GUDID counterpart to copy from. Budget the EU filing as its own exercise.
• Keep the identifiers aligned where you can. If GS1 is your issuing entity in both markets, the same GTIN can serve as the device identifier on both sides — that is the one genuine economy available.
• Expect the EU data to keep filling in. EUDAMED registration only became mandatory on 28 May 2026, with grace periods running to 28 November 2026 for devices already on the market and 27 May 2027 for pre-existing certificates. A comparison of coverage between the two databases made today is a snapshot of a moving target.

MD Atlas indexes the public EUDAMED modules — an indexed subset, not the complete database — which is what lets us show actors, devices and certificates in one place, and why every figure we publish carries that caveat.