UDI and GUDID Submission
A unique device identifier is a code that appears on your device label and identifies the version or model.
A record for each device is published in FDA’s Global Unique Device Identification Database, known as GUDID. Once published, anyone can look up the record — including the customers verifying you before they buy.
We create and publish those records for you, and confirm that the identifier printed on your labeling matches them.
- Responsible
- The labeler
- The code
- Device + production ID
- Published in
- FDA's GUDID
- Visibility
- Public via AccessGUDID
- The identifier
- From an issuing agency
- Our fee
- Quoted per batch
One number has to land in two places.
The identifier is printed on your label and published in your GUDID record. A submission is only finished when the two agree, and a mismatch is visible to everyone who looks either one up.
The number itself is not ours to give you. It comes from an FDA-accredited issuing agency — a separate organization, with its own fee.
The first pressure rarely comes from FDA.
GUDID records are public. Hospitals, distributors and group purchasing organizations use AccessGUDID to confirm that a device is what the supplier says it is.
A device with no published record is difficult for a hospital procurement system to accept, even when the underlying compliance is complete.
| Who looks it up | What they are checking |
|---|---|
| Hospital procurement | Systems that will not accept a device with no published record |
| Distributors and GPOs | Confirming a device is what the supplier says it is |
| Anyone with a browser | AccessGUDID is public, free and needs no account |
| Customs, at the border | Import Alert 99-49: detention without physical examination |
Import Alert 99-49 authorizes detention without physical examination of devices that lack a required UDI, a matching GUDID record, or both.
Scoped, assembled, published, checked.
You send the device list. Everything from working out which of them are covered to confirming the artwork is ours.
Scope
We confirm which of your devices require GUDID records, and which are excepted.
Data elements
We assemble the data FDA requires for each device.
Publication
We create and publish the records in GUDID.
The artwork check
We check that the identifier on your artwork matches the published record.
Upkeep
We update records when a device changes, is discontinued, or a new version is released.
Send the device list. We will tell you which ones need records.
- Quoted per batch
- Scope confirmed first
- Artwork checked against the record
- Updates included
At a glance
| What it is | A device identifier on your label, and a published record for each device in FDA's GUDID database. |
|---|---|
| Who is responsible | The labeler — whoever causes the label to be applied, including manufacturers, specification developers, repackagers and relabelers. |
| The two parts of a UDI | Device identifier, which is mandatory and fixed. Production identifier, which is conditional and varies — lot, serial, expiry or manufacturing date. |
| Where the number comes from | An FDA-accredited issuing agency. That is a separate organization and a separate cost, paid to them and not to FDA or to us. |
| Which devices are covered | Requirements depend on device class, and there are exceptions. We confirm which of yours are covered before quoting. |
| Is it public | Yes. Published records are searchable by anyone through AccessGUDID. |
| Our fee | Quoted per submission batch. Send your device list. |
Questions people ask
Who is the labeler if we manufacture for another company's brand?
The labeler is whoever causes the label to be applied with the intent that the device is commercially distributed. For a device sold under another company's brand, that responsibility usually sits with them rather than with you. Confirm it in writing before either party assumes the other is handling it.
Does every device need a UDI?
Requirements depend on device class and there are exceptions. We confirm which of your devices are covered before quoting.
Do we get the identifier from FDA?
No. Identifiers come from an FDA-accredited issuing agency, which is a separate organization with its own fee.
What happens if our records are wrong?
They are public, so an error is visible to your customers and to FDA. Records can be corrected. We audit your existing GUDID entries against FDA's published data as part of taking on a new client, and tell you what we find before you commit to anything.
Something not covered here? Ask us directly — we answer UDI questions whether or not you end up working with us.
Already published records?
Records can be corrected, but nobody tells you they are wrong. An error sits in the public database until a customer or FDA compares it with the device in front of them.
We audit your existing GUDID entries against FDA’s published data as part of taking on a new client, and tell you what we find before you commit to anything.