Regulatory topic
FDA GUDID: look up a device by its UDI
Most devices sold in the US carry a Unique Device Identifier (UDI) on the label. The device identifier part is published in the FDA's GUDID. MedTech Signal lets you look one up and see each company's identifier portfolio, linked to AccessGUDID.
What a UDI is
A UDI has a device identifier (DI), fixed for one model and package, and a production identifier (lot, serial number, expiry date) that changes per unit. GUDID holds the DI and the device's attributes: brand, model, company, FDA product code, GMDN term, sterility and MRI safety. Production identifiers are not in GUDID.
What it does not show
A GUDID entry is not an FDA clearance or approval, and some devices are exempt from UDI rules. No identifier found never means a device is not sold. We show 'No device identifier found in the FDA GUDID', nothing stronger.
What MedTech Signal shows
Paste a full UDI barcode string, a device identifier, a brand or a model number to fetch matching records live from the FDA. For the companies with the most identifiers, see identifier counts, how many are in commercial distribution, top brands and device types.
Who uses this
Hospitals, purchasing groups and distributors checking what a barcode refers to and cleaning item masters, supply-chain teams mapping products to recalls, and regulatory teams comparing a competitor's US portfolio.
Held: device identifier summaries for roughly the top 1,000 labeling companies by identifier count, refreshed every two weeks. Not held: every individual identifier (looked up live on request) or production identifiers. Source: open.fda.gov device UDI and accessgudid.nlm.nih.gov.