GUDID and ARTG checks by SalesChefWhat is GUDID?
The FDA’s Global Unique Device Identification Database: a reference catalog for every device with a UDI. Device labelers send in the data, and anyone can search it through AccessGUDID.
GUDID and ARTG checks by SalesChef
GUDID and the ARTG, explained for medical device suppliers.
GUDID is the FDA’s Global Unique Device Identification Database, the reference catalog for every device with a unique device identifier (UDI). The ARTG is the TGA’s Australian Register of Therapeutic Goods. In the GS1 system, the GTIN is the device identifier part of a UDI. SalesChef checks every product record against the approved label and the registry record, flags every gap and conflict, and makes product pages that say only what the label says, ready for your team’s review.
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issuing agencies are accredited by the FDA for UDIs: GS1, HIBCC and ICCBBA.
U.S. FDA (opens in a new tab) - 11
markets where GS1 says it is a UDI issuing agency today, including the USA, the European Union and Australia.
GS1 (opens in a new tab)
What are GUDID and the ARTG?
Public records a hospital buyer can check your product against, and the codes that link them.
GUDID
The FDA’s database of device identification information, sent in by device labelers. Anyone can search it through AccessGUDID.
The ARTG
The TGA’s Australian Register of Therapeutic Goods. Each entry has its own ARTG number.
UDI
The unique device identifier on the label: a fixed device identifier (DI) for the model, and a production identifier (PI) for the lot, serial number or dates.
AusUDID
The TGA’s Australian UDI Database. It stores each device’s UDI-DI and links to its entry in the ARTG.
How UDI, GTIN and the registries fit together
The DI names the model
The FDA calls the device identifier the mandatory, fixed part of a UDI. It identifies the labeler and the specific version or model of a device.
The PI names the unit
The production identifier is the variable part: the lot or batch, serial number, expiration date or manufacture date, when the label carries them.
GUDID holds the DI, not the PI
The FDA says GUDID does not include production identifiers. It holds flags that say which ones appear on the label.
A GTIN can be the DI
In the GS1 system, the GTIN is the device identifier. HIBCC and ICCBBA issue UDIs in their own formats.
AusUDID links to the ARTG
The TGA says the data in AusUDID links to the device’s inclusion in the ARTG. One code leads a buyer to both records.
Pages that match the records
When the size, material and pack on your page match the label and the registry, a buyer who checks finds the same thing.
How SalesChef checks device records
Checks against the label and the registry
Every size, material and pack, checked against the approved label and the registry record. Every value shows its source.
Flags every gap
For a range of anesthesia masks from Bosco Medical and VBM, SalesChef flagged the missing registration numbers, dimensions and shelf life, ready to request from each maker.
Settles what disagrees
An old FAQ said ten mask sizes. The record says nine. The two makers color size 4 differently, so SalesChef made one size chart per maker.
Says only what the label says
SalesChef quotes the ARTG number and the label’s own claims, and leaves the rest unsaid. Your regulatory team reviews, and nothing goes live without your yes.
Works with the documents you already have
SalesChef reads the makers’ labels, instructions for use and your range sheets, and sends checked records back where your team works.
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Questions about GUDID and the ARTG
What does GUDID stand for?
Global Unique Device Identification Database. The FDA runs it.
Is GUDID mandatory?
The FDA says that, in general, its UDI rule requires device labelers, typically the manufacturer, to submit device information to GUDID. Your regulatory team decides what applies to your devices.
What is the difference between UDI and GUDID?
The UDI is the code on the device label. GUDID is the FDA database that holds the device identifier part of that code and the device’s key details.
Is a UDI the same as a GTIN?
Not always. In the GS1 system, the GTIN serves as the device identifier, the fixed part of the UDI. A UDI can also carry a production identifier, such as a lot or serial number, and HIBCC and ICCBBA issue other formats.
What is the ARTG?
The Australian Register of Therapeutic Goods, kept by the TGA. You can search it on the TGA website.
What is AusUDID?
The TGA’s Australian UDI Database. It stores unique device identifiers and related data for medical devices supplied in Australia, and links to each device’s ARTG entry.
Does SalesChef give regulatory advice?
No. SalesChef checks product records against the approved label and the registry record, flags gaps and conflicts, and your regulatory team decides.
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